Trial Outcomes & Findings for Efficacy Safety Score in Postoperative Management (NCT NCT03438578)

NCT ID: NCT03438578

Last Updated: 2020-09-24

Results Overview

The measured postoperative time when patient can stand and able to walk one or more steps, with or without support

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2020-09-24

Participant Flow

Participant milestones

Measure	Efficacy Safety Score Monitoring Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care.	Regular Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Overall Study STARTED	100	100
Overall Study COMPLETED	99	96
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Efficacy Safety Score Monitoring n=96 Participants Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care.	Regular n=99 Participants Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward	Total n=195 Participants Total of all reporting groups
Age, Continuous	61 Years STANDARD_DEVIATION 12.5 • n=96 Participants	62 Years STANDARD_DEVIATION 13.3 • n=99 Participants	62 Years STANDARD_DEVIATION 12.9 • n=195 Participants
Sex: Female, Male Female	36 Participants n=96 Participants	37 Participants n=99 Participants	73 Participants n=195 Participants
Sex: Female, Male Male	60 Participants n=96 Participants	62 Participants n=99 Participants	122 Participants n=195 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Norway	96 Participants n=96 Participants	99 Participants n=99 Participants	195 Participants n=195 Participants

PRIMARY outcome

Timeframe: 24 hours

The measured postoperative time when patient can stand and able to walk one or more steps, with or without support

Outcome measures

Measure	Efficacy Safety Score Monitoring n=96 Participants Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care.	Regular n=99 Participants Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Time to Mobilization	10.1 hours Interval 8.1 to 12.2	14.2 hours Interval 12.0 to 16.3

SECONDARY outcome

Timeframe: 24 hours

Reported pain hourly on a 11-digit scale, called Verbal Numeric Rating Scale for pain, 0-10 where 0 is no pain, and 10 is worst thinkable pain. Higher scores mean a worse outcome.

Outcome measures

Measure	Efficacy Safety Score Monitoring n=96 Participants Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care.	Regular n=99 Participants Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Pain Measurement, Verbal Numeric Rating Scale	2.1 score on a scale Interval 1.8 to 2.9	3.3 score on a scale Interval 2.9 to 3.7

SECONDARY outcome

Timeframe: 24 hours

Reported patient satisfaction on a 1-5 scale, (Likert scale), where 1 is Very dissatisfied, and 5 is Very satisfied. Higher scores mean a better outcome.

Outcome measures

Measure	Efficacy Safety Score Monitoring n=96 Participants Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care.	Regular n=99 Participants Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Patient Satisfaction	4.9 score on a scale Interval 4.9 to 5.0	4.3 score on a scale Interval 4.2 to 4.5

Adverse Events

Efficacy Safety Score Monitoring

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Regular

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Efficacy Safety Score Monitoring n=96 participants at risk Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care.	Regular n=99 participants at risk Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Nervous system disorders Neurological seizure	0.00% 0/96 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events	1.0% 1/99 • Number of events 1 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events
Nervous system disorders Stroke	0.00% 0/96 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events	1.0% 1/99 • Number of events 1 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events

Other adverse events

Measure	Efficacy Safety Score Monitoring n=96 participants at risk Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care.	Regular n=99 participants at risk Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Cardiac disorders Hypotension	2.1% 2/96 • Number of events 2 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events	0.00% 0/99 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events
Nervous system disorders Pain treatment, nerve blocks	2.1% 2/96 • Number of events 2 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events	0.00% 0/99 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events
Cardiac disorders Atrial fibrillation	1.0% 1/96 • Number of events 1 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events	0.00% 0/99 • 24 hour after surgery Low blood pressure Arrythmia Need for extra treatment Neurological events

Additional Information

Erlend Johan Skraastad

St Olavs Hospital

Phone: 0047 79829184

Email: Erlend.Johan.Skraastad@stolav.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place