Trial Outcomes & Findings for Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery (NCT NCT03026530)
NCT ID: NCT03026530
Last Updated: 2018-12-05
Results Overview
A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
4, 12, 24, 36 and 48 hours after surgery
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Pulmonary Recruitment Maneuver
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
Control Group
Ordinary ventilation at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
79
|
71
|
|
Overall Study
NOT COMPLETED
|
21
|
29
|
Reasons for withdrawal
| Measure |
Pulmonary Recruitment Maneuver
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
Control Group
Ordinary ventilation at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
24
|
|
Overall Study
Protocol Violation
|
2
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pulmonary Recruitment Maneuver
n=79 Participants
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
Control Group
n=71 Participants
Ordinary ventilation at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=79 Participants
|
44 years
n=71 Participants
|
46 years
n=150 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=79 Participants
|
54 Participants
n=71 Participants
|
121 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=79 Participants
|
17 Participants
n=71 Participants
|
29 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
79 participants
n=79 Participants
|
71 participants
n=71 Participants
|
150 participants
n=150 Participants
|
|
BMI
|
38 kg/m2
n=79 Participants
|
38 kg/m2
n=71 Participants
|
38 kg/m2
n=150 Participants
|
PRIMARY outcome
Timeframe: 4, 12, 24, 36 and 48 hours after surgeryA questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.
Outcome measures
| Measure |
Pulmonary Recruitment Maneuver
n=79 Participants
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
Control Group
n=71 Participants
Ordinary ventilation at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
|---|---|---|
|
Postoperative Pain
36 hr
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Postoperative Pain
48 hr
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.75
|
|
Postoperative Pain
4 hr
|
3 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Postoperative Pain
12 hr
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 4.0
|
|
Postoperative Pain
24 hr
|
2 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 4, 12, 24, 36 and 48 hours after surgeryA questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea.
Outcome measures
| Measure |
Pulmonary Recruitment Maneuver
n=79 Participants
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
Control Group
n=71 Participants
Ordinary ventilation at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator
|
|---|---|---|
|
Postoperative Nausea
NRS 12 hr
|
1 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 2.0
|
|
Postoperative Nausea
36 hr
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Postoperative Nausea
4 hr
|
1 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
|
Postoperative Nausea
24 hr
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Postoperative Nausea
48 hr
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
Adverse Events
Pulmonary Recruitment Maneuver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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