Trial Outcomes & Findings for Effect of Recruitment Maneuver on Postoperative Atelectasis Assessed by Lung Ultrasound in Laparoscopic Cholecystectomy (NCT NCT07324122)
NCT ID: NCT07324122
Last Updated: 2026-03-04
Results Overview
Lung ultrasound score (LUS) assessed using a 12-zone scanning technique. Each zone is scored from 0 (normal aeration, A-lines) to 3 (lung consolidation). Total score ranges from 0 to 36, with higher scores indicating worse lung aeration. Change calculated as difference from baseline (T0) to T1 and T2.
COMPLETED
80 participants
Baseline (T0), 30 minutes after pneumoperitoneum (T1), and 30 minutes after desufflation (T2)
2026-03-04
Participant Flow
Participants were prospectively recruited from adult patients scheduled for elective laparoscopic cholecystectomy at a tertiary care hospital according to predefined inclusion and exclusion criteria.
All participants who met the eligibility criteria were enrolled and assigned to the study groups. No participants were excluded prior to assignment.
Participant milestones
| Measure |
Protective Ventilation Group
Participants in this group received lung-protective mechanical ventilation during laparoscopic cholecystectomy, including low tidal volume ventilation with positive end-expiratory pressure.
|
Conventional Ventilation Group
Participants in this group received conventional mechanical ventilation during laparoscopic cholecystectomy according to standard institutional practice.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Protective Ventilation Group
n=40 Participants
Participants in this group received lung-protective mechanical ventilation during laparoscopic cholecystectomy, including low tidal volume ventilation with positive end-expiratory pressure.
|
Conventional Ventilation Group
n=40 Participants
Participants in this group received conventional mechanical ventilation during laparoscopic cholecystectomy according to standard institutional practice.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 13.2 • n=40 Participants
|
46.8 years
STANDARD_DEVIATION 14.1 • n=40 Participants
|
46.05 years
STANDARD_DEVIATION 13.65 • n=80 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=40 Participants
|
24 Participants
n=40 Participants
|
50 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=40 Participants
|
16 Participants
n=40 Participants
|
30 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
27.8 kg/m²
STANDARD_DEVIATION 4.5 • n=40 Participants
|
28.2 kg/m²
STANDARD_DEVIATION 4.3 • n=40 Participants
|
28 kg/m²
STANDARD_DEVIATION 4.4 • n=80 Participants
|
PRIMARY outcome
Timeframe: Baseline (T0), 30 minutes after pneumoperitoneum (T1), and 30 minutes after desufflation (T2)Population: No participants were excluded from analysis.
Lung ultrasound score (LUS) assessed using a 12-zone scanning technique. Each zone is scored from 0 (normal aeration, A-lines) to 3 (lung consolidation). Total score ranges from 0 to 36, with higher scores indicating worse lung aeration. Change calculated as difference from baseline (T0) to T1 and T2.
Outcome measures
| Measure |
Protective Ventilation Group
n=40 Participants
Participants in this group received lung-protective mechanical ventilation during laparoscopic cholecystectomy, including low tidal volume ventilation with positive end-expiratory pressure.
|
Conventional Ventilation Group
n=40 Participants
Participants in this group received conventional mechanical ventilation during laparoscopic cholecystectomy according to standard institutional practice.
|
|---|---|---|
|
Change in Lung Ultrasound Score (LUS)
Time Point: Baseline (T0)
|
5.2 points
Standard Deviation 2.1
|
5.4 points
Standard Deviation 2.3
|
|
Change in Lung Ultrasound Score (LUS)
Time Point: T1 (30 min after pneumoperitoneum)
|
8.7 points
Standard Deviation 2.8
|
12.5 points
Standard Deviation 3.2
|
|
Change in Lung Ultrasound Score (LUS)
Time Point: T2 (30 min after desufflation)
|
6.3 points
Standard Deviation 2.4
|
9.8 points
Standard Deviation 2.9
|
Adverse Events
Protective Ventilation Group
Conventional Ventilation Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Protective Ventilation Group
n=40 participants at risk
Participants in this group received lung-protective mechanical ventilation during laparoscopic cholecystectomy, including low tidal volume ventilation with positive end-expiratory pressure.
|
Conventional Ventilation Group
n=40 participants at risk
Participants in this group received conventional mechanical ventilation during laparoscopic cholecystectomy according to standard institutional practice.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Postoperative atelectasis
|
7.5%
3/40 • Number of events 3 • From anesthesia induction through hospital discharge (approximately 3-5 days postoperatively)
Adverse events were monitored from the time of anesthesia induction until hospital discharge. All respiratory complications and events requiring intervention were recorded.
|
30.0%
12/40 • Number of events 12 • From anesthesia induction through hospital discharge (approximately 3-5 days postoperatively)
Adverse events were monitored from the time of anesthesia induction until hospital discharge. All respiratory complications and events requiring intervention were recorded.
|
Additional Information
Name: Cansu Oflıuoglu, MD Official Title: Principal Investigator, Department of Anesthesiology
Fatih Sultan Mehmet Training and Research Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place