Trial Outcomes & Findings for Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care (NCT NCT00542321)
NCT ID: NCT00542321
Last Updated: 2016-04-06
Results Overview
Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Participants were followed for the duration of ICU stay, an average of 10 days.
Results posted on
2016-04-06
Participant Flow
Recruitment period spanned 8.6 months (between 09/28/07 - 04/30/07 and 05/01/09 - 08/31/09) and was done in 2 ICUs of 2 tertiary hospitals. Recruitment efforts were intermittent due to staffing resources and reconfiguration and testing of automated turn bed angle sensor.
Not applicable. All enrolled patients assigned to group.
Participant milestones
| Measure |
Kinetic Therapy Bed
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Kinetic Therapy Bed
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care
Baseline characteristics by cohort
| Measure |
Kinetic Therapy Bed
n=8 Participants
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
n=8 Participants
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Vasopressor Use
Presence
|
3 Participant
n=5 Participants
|
3 Participant
n=7 Participants
|
6 Participant
n=5 Participants
|
|
Vasopressor Use
Absence
|
5 Participant
n=5 Participants
|
5 Participant
n=7 Participants
|
10 Participant
n=5 Participants
|
|
COPD Diagnosis
Yes
|
0 Participant
n=5 Participants
|
4 Participant
n=7 Participants
|
4 Participant
n=5 Participants
|
|
COPD Diagnosis
No
|
8 Participant
n=5 Participants
|
4 Participant
n=7 Participants
|
12 Participant
n=5 Participants
|
|
Surgery
Yes
|
3 Participant
n=5 Participants
|
2 Participant
n=7 Participants
|
5 Participant
n=5 Participants
|
|
Surgery
No
|
5 Participant
n=5 Participants
|
6 Participant
n=7 Participants
|
11 Participant
n=5 Participants
|
|
APACHE II
|
24 Scores on a scale
STANDARD_DEVIATION 5 • n=5 Participants
|
27 Scores on a scale
STANDARD_DEVIATION 9 • n=7 Participants
|
25 Scores on a scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
FIO2
|
0.73 Fraction
STANDARD_DEVIATION 0.25 • n=5 Participants
|
0.77 Fraction
STANDARD_DEVIATION 0.28 • n=7 Participants
|
0.75 Fraction
STANDARD_DEVIATION 0.26 • n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of ICU stay, an average of 10 days.Population: Intention to treat; all 8 patients enrolled in kinetic therapy bed turn and 7 of 8 patients enrolled in manual turn (1 died before protocol initiated)
Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups.
Outcome measures
| Measure |
Kinetic Therapy Bed
n=8 Participants
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
n=7 Participants
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
Incidence of Pulmonary Complications.
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.Population: All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 death before study protocol initiated)
Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation
Outcome measures
| Measure |
Kinetic Therapy Bed
n=8 Participants
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
n=7 Participants
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
Mechanical Ventilation Duration.
|
5.97 Days
Standard Deviation 4.99
|
5.21 Days
Standard Deviation 4.29
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of ICU stay, an average of 10 days.Population: All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 patient enrolled but died before started on protocol)
Time in days from study ICU admission to study ICU discharge or death
Outcome measures
| Measure |
Kinetic Therapy Bed
n=8 Participants
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
n=7 Participants
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
ICU Length of Stay.
|
11.1 Days
Interval 5.4 to 23.4
|
8.2 Days
Interval 3.6 to 14.9
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of ICU stay, an average of 10 days.Population: All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died before start of study protocol)
Death from any reason between admission and discharge from study ICU
Outcome measures
| Measure |
Kinetic Therapy Bed
n=8 Participants
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
n=7 Participants
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
ICU All-cause Mortality.
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of time on protocol, an average of 3.5 days.Population: All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died after enrollment but before protocol could be initiated)
Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group
Outcome measures
| Measure |
Kinetic Therapy Bed
n=8 Participants
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
n=7 Participants
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
Turning-related Events
|
138 Events
Standard Deviation 131
|
125 Events
Standard Deviation 87
|
Adverse Events
Kinetic Therapy Bed
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Manual Turn
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Kinetic Therapy Bed
n=8 participants at risk
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
n=7 participants at risk
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
General disorders
Death
|
12.5%
1/8 • Number of events 1 • Time on protocol (7 days or less)
|
0.00%
0/7 • Time on protocol (7 days or less)
|
|
Cardiac disorders
Dysrhythmia
|
12.5%
1/8 • Number of events 2 • Time on protocol (7 days or less)
|
14.3%
1/7 • Number of events 1 • Time on protocol (7 days or less)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
12.5%
1/8 • Number of events 1 • Time on protocol (7 days or less)
|
0.00%
0/7 • Time on protocol (7 days or less)
|
|
Respiratory, thoracic and mediastinal disorders
Inadvertent extubation
|
0.00%
0/8 • Time on protocol (7 days or less)
|
14.3%
1/7 • Number of events 1 • Time on protocol (7 days or less)
|
|
General disorders
Hypertension
|
37.5%
3/8 • Number of events 3 • Time on protocol (7 days or less)
|
0.00%
0/7 • Time on protocol (7 days or less)
|
|
General disorders
Hypotension
|
0.00%
0/8 • Time on protocol (7 days or less)
|
14.3%
1/7 • Number of events 1 • Time on protocol (7 days or less)
|
|
Respiratory, thoracic and mediastinal disorders
Ventilator Disconnection
|
12.5%
1/8 • Number of events 1 • Time on protocol (7 days or less)
|
0.00%
0/7 • Time on protocol (7 days or less)
|
|
Respiratory, thoracic and mediastinal disorders
Ventilator malfunction
|
0.00%
0/8 • Time on protocol (7 days or less)
|
14.3%
1/7 • Number of events 1 • Time on protocol (7 days or less)
|
Other adverse events
| Measure |
Kinetic Therapy Bed
n=8 participants at risk
Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
|
Manual Turn
n=7 participants at risk
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
|
|---|---|---|
|
Psychiatric disorders
Discomfort:Psychologic
|
100.0%
8/8 • Number of events 227 • Time on protocol (7 days or less)
|
100.0%
7/7 • Number of events 300 • Time on protocol (7 days or less)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
100.0%
8/8 • Number of events 525 • Time on protocol (7 days or less)
|
100.0%
7/7 • Number of events 213 • Time on protocol (7 days or less)
|
|
Vascular disorders
Hemodynamic
|
100.0%
8/8 • Number of events 237 • Time on protocol (7 days or less)
|
85.7%
6/7 • Number of events 243 • Time on protocol (7 days or less)
|
|
General disorders
Discomfort:Physiologic
|
100.0%
8/8 • Number of events 59 • Time on protocol (7 days or less)
|
85.7%
6/7 • Number of events 74 • Time on protocol (7 days or less)
|
|
General disorders
Miscellaneous
|
75.0%
6/8 • Number of events 48 • Time on protocol (7 days or less)
|
57.1%
4/7 • Number of events 36 • Time on protocol (7 days or less)
|
|
Skin and subcutaneous tissue disorders
Skin
|
12.5%
1/8 • Number of events 4 • Time on protocol (7 days or less)
|
42.9%
3/7 • Number of events 8 • Time on protocol (7 days or less)
|
Additional Information
Sandra K. Hanneman, PhD, RN, FAAN
University of Texas Health Science Center at Houston
Phone: 713-500-2030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place