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CompletedNCT05494255

The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis

The Effects of Pre-extubation Single Recruitment Maneuver on Lung Ultrasound Scores and Postoperative Oxygenation in Laparoscopic Nephrectomy Surgeries

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Istanbul University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult after the surgery. Lung Ultrasound Scoring (LUS) can provide an objective measuring system to understand the condition of the lungs in the perioperative period. In this randomized controlled study, it is aimed to investigate the effects of one single recruitment maneuver (RM) just before emergence and extubation (at the end of surgery) on LUS scores and postoperative recovery room oxygenation in laparoscopic nephrectomy surgeries. Accordingly, the intervention group will be applied single RM before extubation, while the control group will be awaken without RM. There will be LUS evaluation at 4 different time for intervention group (Group RM) points that are: T1: 5 min after the intubation T2: At the end of surgery (After skin closure, before recruitment maneuver) T3(RM): After recruitment maneuver, before extubation T4: 30 minutes after extubation in the recovery room LUS evaluation will be made at 3 different time points in control group (Group NoRM): T1: 5 min after the intubation T3(NoRM): Before extubation (no recruitment maneuvers will be made) T4: 30 minutes after extubation in the recovery room. The primary outcome is the comparison of the T3 LUS scores. Assuming a 40% difference in the T3 LUS score, total number of 30 patients were calculated to be included in the study with an alpha value of 0.05 and 95% power. A possible drop-out of 5 patients per group, 20 patients were planned to be enrolled in each group. Secondary outcomes will include; difference in T4 LUS scores, the effect of RM on postoperative recovery room oxygenation, and the effect of deltaLUS (T3-T2) on postoperative recovery room oxygenation.

Conditions

Interventions

TypeNameDescription
OTHERRecruitment maneuverIn Group RM (intervention group) after skin closure, mechanical ventilation settings will be set to FiO2:100%, I:E=1:1, respiratory rate: 6, and then tidal volume will be increased gradually by 150 ml until reaching a plato pressure of 30 mmHg. After 3 breaths in this state, RM will be considered accomplished. LUS evaluation will be made just before and after the RM.

Timeline

Start date
2022-08-11
Primary completion
2023-05-02
Completion
2023-05-04
First posted
2022-08-09
Last updated
2023-05-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05494255. Inclusion in this directory is not an endorsement.