Trial Outcomes & Findings for Exploration of Investigating ICU Mobilisation With Vasoactive Drugs (NCT NCT03869541)
NCT ID: NCT03869541
Last Updated: 2021-11-11
Results Overview
The number of patient participants who would hypothetically accept being randomised into a future trial on the safety of mobilising patients receiving vasoactive drugs.
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
Baseline (approximately one day from enrolment)
Results posted on
2021-11-11
Participant Flow
Participant milestones
| Measure |
Intensive Care Patients
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Unit Clinicians
Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
ICU Rehabilitation Clinicians
Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
50
|
10
|
|
Overall Study
COMPLETED
|
40
|
50
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data only collected for Intensive care patients arm for this baseline measure.
Baseline characteristics by cohort
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Clinicians
n=50 Participants
Clinicians for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Rehabilitation Clinicians
n=10 Participants
Clinicians for participation in a survey on the feasibility of an ICU physical rehabilitation adverse event tool.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
66 years
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
|
Sex: Female, Male
Female
|
14 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
14 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
|
Sex: Female, Male
Male
|
26 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
26 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
|
Race/Ethnicity, Customized
Ethnicity · Black/African/Caribbean/Black British
|
3 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
3 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
29 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
29 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
|
Race/Ethnicity, Customized
Ethnicity · Other / not stated
|
8 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
8 Participants
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
|
Region of Enrollment
United Kingdom
|
40 participants
n=40 Participants
|
50 participants
n=50 Participants
|
10 participants
n=10 Participants
|
100 participants
n=100 Participants
|
|
BMI
|
26 kg/m^2
n=35 Participants • Number analysed in row differs from overall due to missing data. Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
26 kg/m^2
n=35 Participants • Number analysed in row differs from overall due to missing data. Data only collected for Intensive care patients arm for this baseline measure.
|
|
APACHE (Acute physiology and chronic health evaluation)II score
|
16 units on a scale
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
16 units on a scale
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
|
Sequential Organ Failure Assessment (SOFA) score
|
6 units on a scale
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
—
|
—
|
6 units on a scale
n=40 Participants • Data only collected for Intensive care patients arm for this baseline measure.
|
|
Duration of invasive mechanical ventilation
|
0 days
n=40 Participants • Baseline measure only recorded for intensive care patients arm.
|
—
|
—
|
0 days
n=40 Participants • Baseline measure only recorded for intensive care patients arm.
|
|
Profession
Doctor
|
—
|
17 Participants
n=50 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
0 Participants
n=10 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
17 Participants
n=60 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
|
Profession
Nurse
|
—
|
26 Participants
n=50 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
0 Participants
n=10 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
26 Participants
n=60 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
|
Profession
Physiotherapist
|
—
|
7 Participants
n=50 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
10 Participants
n=10 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
17 Participants
n=60 Participants • Data not collected for Intensive care patients arm for this baseline measure.
|
|
ICU experience
|
—
|
11 Years
n=48 Participants • Missing data for two participants. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care rehabilitation clinicians, however this has been summarized with a different measure type and dispersion, therefore is reported as a separate variable.
|
—
|
11 Years
n=48 Participants • Missing data for two participants. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care rehabilitation clinicians, however this has been summarized with a different measure type and dispersion, therefore is reported as a separate variable.
|
|
ICU experience of rehabilitation clinicians
|
—
|
—
|
6 Years
STANDARD_DEVIATION 5 • n=9 Participants • Missing data for one participant. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care clinicians arms, but summarised as a different measure type and dispersion, therefore reported as a different baseline measure.
|
6 Years
STANDARD_DEVIATION 5 • n=9 Participants • Missing data for one participant. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care clinicians arms, but summarised as a different measure type and dispersion, therefore reported as a different baseline measure.
|
|
Healthcare experience
|
—
|
16 Years
n=48 Participants • Missing data for two participants. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care rehabilitation clinicians, however this was summarized as a different measure type and dispersion, therefore this is displayed as a separate variable.
|
—
|
16 Years
n=48 Participants • Missing data for two participants. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care rehabilitation clinicians, however this was summarized as a different measure type and dispersion, therefore this is displayed as a separate variable.
|
|
Healthcare experience of rehabilitation clinicians
|
—
|
—
|
9 Years
STANDARD_DEVIATION 6 • n=9 Participants • Missing data for one participant. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care clinicians, however this was summarized as a different measure type and dispersion, therefore this is represented as a different baseline measure.
|
9 Years
STANDARD_DEVIATION 6 • n=9 Participants • Missing data for one participant. Data not collected for Intensive care patients arm for this baseline measure. Data was collected for intensive care clinicians, however this was summarized as a different measure type and dispersion, therefore this is represented as a different baseline measure.
|
PRIMARY outcome
Timeframe: Baseline (approximately one day from enrolment)Population: Number of participants without missing data for this outcome
The number of patient participants who would hypothetically accept being randomised into a future trial on the safety of mobilising patients receiving vasoactive drugs.
Outcome measures
| Measure |
Intensive Care Patients
n=37 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Hypothetical Recruitment Rate for a Future Randomised Controlled Trial.
|
30 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Total number of participants in this participant group
Patient participant follow-up rate at 60 days.
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Participants With Follow-up at 60 Days
|
40 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (approximately one day from enrolment)Population: For each of the 40 patient participants, number of randomisation surveys completed by the four groups described above.
Survey measuring participant acceptance of hypothetical randomisation scenarios: scenario 1: early versus no rehabilitation
Outcome measures
| Measure |
Intensive Care Patients
n=37 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
n=32 Participants
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
n=34 Participants
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
n=40 Participants
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Participants Rating the 'Early Versus no Rehabilitation' Randomisation Scenario Was Acceptable
|
15 Participants
|
11 Participants
|
18 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline (approximately one day from enrolment)Population: For each of the 40 patient participants, number of randomization surveys completed by the four groups described above.
Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 2: early rehabilitation versus standard care
Outcome measures
| Measure |
Intensive Care Patients
n=37 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
n=32 Participants
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
n=34 Participants
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
n=40 Participants
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Participants Rating the 'Early Rehabilitation Versus Standard Care' Randomization Scenario as Acceptable
|
25 Participants
|
30 Participants
|
28 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Baseline (approximately one day from enrolment)Population: For each of the 40 patient participants, number of randomisation surveys completed by the four groups described above.
Survey measuring participant acceptance of hypothetical randomization scenarios: scenario 3: protocolised rehabilitation versus standard care
Outcome measures
| Measure |
Intensive Care Patients
n=36 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
n=32 Participants
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
n=35 Participants
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
n=40 Participants
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Participants Rating the 'Protocolised Rehabilitation Versus Standard Care' Randomisation Scenario as Acceptable
|
24 Participants
|
28 Participants
|
27 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline (approximately one day from enrolment)Population: Number of participants for whom pre-morbid evaluation of comorbidities was attempted.
Quantity of missing data resulting from measurement of participant pre-morbid co-morbidities.
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Participants Where Participant Pre-morbid Comorbidities Measurement Was Not Completed.
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (approximately one day from enrolment)Population: Number of participants for whom pre-morbid evaluation of frailty was attempted.
Quantity of missing data resulting from measurement of participant pre-morbid frailty.
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Participants Where Participant Pre-morbid Frailty Measurements Were Not Completed.
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (approximately one day from enrolment)Population: Number of participants for whom the pre-morbid measurement of physical function was attempted.
Quantity of missing data resulting from measurement of participant pre-morbid physical function.
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Participants Where Participant Pre-morbid Physical Function Measurement Was Not Completed.
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of ICU stay (average of 7 days).Population: Number of mobilization treatments where data was available for analysis. Please note the categories presented below are not mutually exclusive e.g. a decision whether to mobilize could have been made with a nurse and a doctor. Therefore, the sum of the categories will be greater than the overall number of participants analyzed.
Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized.
Outcome measures
| Measure |
Intensive Care Patients
n=21 Treatment sessions
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Who Made the Final Decision Whether to Mobilize the Patient
Alone
|
9 Treatment sessions
|
—
|
—
|
—
|
|
Who Made the Final Decision Whether to Mobilize the Patient
Nurse
|
7 Treatment sessions
|
—
|
—
|
—
|
|
Who Made the Final Decision Whether to Mobilize the Patient
Lead physiotherapist
|
3 Treatment sessions
|
—
|
—
|
—
|
|
Who Made the Final Decision Whether to Mobilize the Patient
Senior doctor
|
1 Treatment sessions
|
—
|
—
|
—
|
|
Who Made the Final Decision Whether to Mobilize the Patient
Doctor in charge
|
4 Treatment sessions
|
—
|
—
|
—
|
|
Who Made the Final Decision Whether to Mobilize the Patient
Surgical team
|
1 Treatment sessions
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of ICU stay (average of 7 days).Population: Number of mobilization treatments where data was available for analysis
Recorded whenever a physiotherapist reviews a patient participant for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was mobilized. Qualitative measure: reasons underwent content analysis, with the outcome being the themes summarizing the reasons.
Outcome measures
| Measure |
Intensive Care Patients
n=1 Entire group where data available
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
The Reasons for the Decision When Patient Was Mobilized.
Vasoactive dose decreasing and blood pressure improved
|
1 Entire group where data available
|
—
|
—
|
—
|
|
The Reasons for the Decision When Patient Was Mobilized.
Cardiovascularly stable and/or minimal vasoactive drug dose
|
1 Entire group where data available
|
—
|
—
|
—
|
|
The Reasons for the Decision When Patient Was Mobilized.
Was cardiovascularly stable on initial cautious mobilisation.
|
1 Entire group where data available
|
—
|
—
|
—
|
|
The Reasons for the Decision When Patient Was Mobilized.
Post-operative
|
1 Entire group where data available
|
—
|
—
|
—
|
|
The Reasons for the Decision When Patient Was Mobilized.
Rationale for chest optimisation and improve strength and function.
|
1 Entire group where data available
|
—
|
—
|
—
|
|
The Reasons for the Decision When Patient Was Mobilized.
To assess strength and alertness
|
1 Entire group where data available
|
—
|
—
|
—
|
|
The Reasons for the Decision When Patient Was Mobilized.
Surgical wound safe to mobilise / medically stable
|
1 Entire group where data available
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of intensive care stay (average 7 days)Population: Number of reviews by a physiotherapist where patient was not mobilized and where data was available. i.e. the overall number of participants analyzed/denominator is actually the overall number of physiotherapist reviews. Please note the categories presented below are not mutually exclusive e.g. the decision not to mobilize could have been made with a nurse and a physiotherapist. Therefore, the sum of the categories exceeds with overall number of participants analyzed.
Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized.
Outcome measures
| Measure |
Intensive Care Patients
n=29 Number of treatment reviews
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Who Made the Final Decision Whether to Not Mobilize the Patient
Alone
|
20 Reviews
|
—
|
—
|
—
|
|
Who Made the Final Decision Whether to Not Mobilize the Patient
Lead physiotherapist
|
6 Reviews
|
—
|
—
|
—
|
|
Who Made the Final Decision Whether to Not Mobilize the Patient
Nurse
|
3 Reviews
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of intensive care stay (average 7 days)Population: Number of reviews by a physiotherapist where patient was not mobilized and where data was available.
Recorded whenever a physiotherapist reviews a patient for potential physical rehabilitation whilst they are receiving vasoactive drugs and the patient was not mobilized. Qualitative variable: reasons underwent qualitative analysis, with the output of a list of themes summarizing the reasons.
Outcome measures
| Measure |
Intensive Care Patients
n=1 Whole group where data was available
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
The Reasons for the Decision When the Patient Was Not Mobilized.
Patient sedated / drowsy / confused
|
1 Whole group where data was available
|
—
|
—
|
—
|
|
The Reasons for the Decision When the Patient Was Not Mobilized.
Patient fatigue
|
1 Whole group where data was available
|
—
|
—
|
—
|
|
The Reasons for the Decision When the Patient Was Not Mobilized.
Patient too unwell
|
1 Whole group where data was available
|
—
|
—
|
—
|
|
The Reasons for the Decision When the Patient Was Not Mobilized.
Blood pressure low and/or increasing/high vasoactive drug dose
|
1 Whole group where data was available
|
—
|
—
|
—
|
|
The Reasons for the Decision When the Patient Was Not Mobilized.
Lack of staff
|
1 Whole group where data was available
|
—
|
—
|
—
|
|
The Reasons for the Decision When the Patient Was Not Mobilized.
Pain
|
1 Whole group where data was available
|
—
|
—
|
—
|
|
The Reasons for the Decision When the Patient Was Not Mobilized.
Did not give consent
|
1 Whole group where data was available
|
—
|
—
|
—
|
|
The Reasons for the Decision When the Patient Was Not Mobilized.
Filter
|
1 Whole group where data was available
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of ICU stay (average of 7 days).Population: Number of treatment sessions for whom data was available
Recorded if a mobilisation treatment on vasoactive drugs is routinely carried out.
Outcome measures
| Measure |
Intensive Care Patients
n=21 Treatment sessions
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
The Reason Why a Mobilisation Treatment Was Stopped
Aim of session achieved
|
10 Treatments
|
—
|
—
|
—
|
|
The Reason Why a Mobilisation Treatment Was Stopped
Declined
|
1 Treatments
|
—
|
—
|
—
|
|
The Reason Why a Mobilisation Treatment Was Stopped
Symptomatic hypotension
|
2 Treatments
|
—
|
—
|
—
|
|
The Reason Why a Mobilisation Treatment Was Stopped
Patient weakness/fatigue
|
6 Treatments
|
—
|
—
|
—
|
|
The Reason Why a Mobilisation Treatment Was Stopped
Pain/discomfort
|
2 Treatments
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through whole of study, an estimated 6 monthsPopulation: Number of mobilization treatment sessions for whom data was available
Number of serious adverse events
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Serious Adverse Events
|
0 events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of ICU stay (average of 7 days).Population: Number of treatment sessions
Recorded using ICU physical rehabilitation adverse event tool, both by treating clinician and by researcher case note review.
Outcome measures
| Measure |
Intensive Care Patients
n=42 Treatment sessions
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of ICU Physical Rehabilitation Adverse Events
Measured by clinicians
|
3 events
|
—
|
—
|
—
|
|
Number of ICU Physical Rehabilitation Adverse Events
Measured by researchers
|
6 events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of ICU stay (average of 7 days).Population: Number of mobilization treatments where adverse event tool used and data available for how long it took to complete.
Adverse event tool is completed if a mobilisation treatment on vasoactive drugs is routinely carried out.
Outcome measures
| Measure |
Intensive Care Patients
n=5 Treatment sessions
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.
< 1 minute
|
2 Treatments
|
—
|
—
|
—
|
|
Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.
1-3 minutes
|
2 Treatments
|
—
|
—
|
—
|
|
Time Taken to Complete an ICU Physical Rehabilitation Adverse Event Tool.
5-10 minutes
|
1 Treatments
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of ICU stay (average of 7 days).Population: Number of mobilization treatment sessions whilst receiving vasoactive drugs
Tool completed both by treating clinician and by researcher case note review. Number of mobilization treatment sessions on vasoactive drugs where adverse event tool is complete.
Outcome measures
| Measure |
Intensive Care Patients
n=42 Treatment sessions
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool.
Completed by clinicians
|
19 Treatments
|
—
|
—
|
—
|
|
Loss of Information That Occurs When Completing ICU Physical Rehabilitation Adverse Event Tool.
Completed by researcher
|
41 Treatments
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through second half of the study, an estimated 3 monthsPopulation: Number of clinicians who completed the survey
A survey measuring user opinion on whether an adverse event tool was for example understandable and an appropriate length using a scale with 'yes', 'no' or 'unsure' responses. Survey adapted from Hodgson, C., Needham, D., Haines, K., Bailey, M., Ward, A., Harrold, M., Young, P., Zanni, J., Buhr, H., Higgins, A., Presneill, J. \& Berney, S. 2014. Feasibility and inter-rater reliability of the ICU mobility scale. Heart Lung, 43.
Outcome measures
| Measure |
Intensive Care Patients
n=10 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Clear, easy to understand?
|
10 Participants
|
—
|
—
|
—
|
|
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Indicate its overall purpose?
|
9 Participants
|
—
|
—
|
—
|
|
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Will people filling out the tool know how to?
|
8 Participants
|
—
|
—
|
—
|
|
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Are the adverse events adequately defined?
|
10 Participants
|
—
|
—
|
—
|
|
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Are the adverse events irrelevant or misleading?
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Are the adverse events offensive or inappropriate?
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Are adverse events unnecessary or repetitive?
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility and Usability of an ICU Physical Rehabilitation Adverse Event Tool Measured by Survey.
Is the tool an appropriate length?
|
10 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of hospital stay (average of 22 days)Population: Number of participants with data available for this outcome.
Number of days to first rehabilitation treatment
Outcome measures
| Measure |
Intensive Care Patients
n=29 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Time to First Mobilisation Treatment
|
2 Days
Interval 1.0 to 7.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of hospital stay (average of 22 days)Population: Number of patient participants with data available.
Regardless of the assistance required.
Outcome measures
| Measure |
Intensive Care Patients
n=33 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Time to First Being Able to Sit Out of Bed.
|
5 Days
Interval 2.0 to 10.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of hospital stay (average of 22 days).Population: Number of participants with data available.
Regardless of the assistance required.
Outcome measures
| Measure |
Intensive Care Patients
n=31 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Time to First Being Able to Stand.
|
3 Days
Interval 2.0 to 11.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through duration of hospital stay (average of 22 days).Population: Number of participants with data available.
Regardless of assistance required.
Outcome measures
| Measure |
Intensive Care Patients
n=28 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Time to First Being Able to Walk.
|
8 Days
Interval 4.0 to 21.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From admission to ICU discharge (an average of 7 days)Population: Number of participants
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Intensive Care Unit Length of Stay.
|
7 Days
Interval 4.0 to 12.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From admission to hospital discharge (average of 22 days)Population: Number of participants
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Hospital Length of Stay
|
16 Days
Interval 9.0 to 32.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: ICU discharge (an average of 7 days from ICU admission)Population: Number of participants with data available.
Intensive care unit mobility scale records a patient's mobility level from 0 to 10, where 0 means no mobility and 10 means walking without assistance from people or a physical aid.
Outcome measures
| Measure |
Intensive Care Patients
n=38 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Intensive Care Unit Mobility Scale Level at ICU Discharge.
|
5 Score on a scale
Interval 3.0 to 6.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 60 days.Population: Number of participants
Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Number of Patient Participants Where All Candidate Primary Outcomes Are Completed.
|
6 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 60 days.Population: Number of participants
Candidate primary outcomes: mortality, health-related quality of life, disability, physical functioning questionnaire and walking test.
Outcome measures
| Measure |
Intensive Care Patients
n=40 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Mortality
|
40 participants
|
—
|
—
|
—
|
|
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Health-related quality of life
|
16 participants
|
—
|
—
|
—
|
|
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Disability
|
15 participants
|
—
|
—
|
—
|
|
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Physical functioning - patient reported
|
15 participants
|
—
|
—
|
—
|
|
The Number of Patient Participants Who Completed Each Individual Candidate Primary Outcome.
Physical functioning - performance-based
|
6 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 60 days.Population: Number of participants with data available
Measures of central tendency and variability of data for candidate outcome measures to inform a sample size for future randomised controlled trial, e.g. physical functioning measured by the physical function domain of the RAND 36-Item Health Survey 1.0 Questionnaire (RAND SF-36 v1), scores range from 0-100, where a higher score means better physical functioning.
Outcome measures
| Measure |
Intensive Care Patients
n=15 Participants
Adult intensive care patients receiving vasoactive drugs
Mobilization: Physical rehabilitation
|
Intensive Care Doctors
Intensive care doctors for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Nurses
Intensive care nurses for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
Intensive Care Physiotherapists
Intensive care physiotherapists for participation in a survey on the hypothetical randomization of patient participants in a future randomized controlled trial.
|
|---|---|---|---|---|
|
Data to Inform a Future Sample Size for a Future Randomized Controlled Trial.
|
20 Units on a scale
Interval 0.0 to 50.0
|
—
|
—
|
—
|
Adverse Events
Intensive Care Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Intensive Care Unit Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ICU Rehabilitation Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place