The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis
NCT ID: NCT05494255
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-08-11
2023-05-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Group RM
One single recruitment maneuver will be applied in this group at the end of the surgery and before the extubation
Recruitment maneuver
In 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.
Group NoRM
Usual care will be applied in this group
No interventions assigned to this group
Interventions
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Recruitment maneuver
In 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.
Eligibility Criteria
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Inclusion Criteria
* Laporoscopic nephrectomy patients who will be operated in lateral positions
* Elective, semi-elective surgeries
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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Emre Sertaç Bingül
Principal investigator, Lecturer, Medical Doctor
Locations
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Istanbul University Istanbul Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2022/1066
Identifier Type: -
Identifier Source: org_study_id
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