Clinical trial NCT05494255: The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis
Official title: The Effects of Pre-extubation Single Recruitment Maneuver on Lung Ultrasound Scores and Postoperative Oxygenation in Laparoscopic Nephrectomy Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Laporoscopic nephrectomy patients who will be operated in lateral positions
* Elective, semi-elective surgeries

Exclusion Criteria:

* Patients with emphysema
* Patients with documanted heart failure
* Patients requiring intraoperative multiple recruitment maneuver due to hypoxemia
* Patients with hemodynamic instability
* Patients with pneumothorax risk
* Emergency surgery
* Patients requiring intraoperative liberal fluid therapy (\>10 cc/kg/hr)
* Patients requiring blood products

Primary outcomes:
measure: Comparison of the pre-extubation LUS scores (T3)
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Comparison of recovery room LUS scores (T4)
timeFrame: Up to 4.5 hours
measure: Comparison of recovery room PaO2
timeFrame: Up to 4.5 hours
measure: The effect of deltaLUS (T3-T2) on oxygenation
timeFrame: Up to 4.5 hours
measure: Length of stay in post anesthesia care unit (PACU)
timeFrame: Up to 4 hours
measure: Length of stay in hospital
timeFrame: Up to 2 weeks
measure: Postoperative respiratory complications
timeFrame: Up to 5 days
measure: Predictive value of dependant lung T3 (preextubation) LUS score detecting postoperative pulmonary complications
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
Study officials:
References: