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

I

Istanbul University

Status

Completed

Conditions

Pulmonary Atelectasis

Treatments

Other: Recruitment maneuver

Study type

Interventional

Funder types

Other

Identifiers

NCT05494255
2022/1066

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Group RM
Active Comparator group
Description:
One single recruitment maneuver will be applied in this group at the end of the surgery and before the extubation
Treatment:
Other: Recruitment maneuver
Group NoRM
No Intervention group
Description:
Usual care will be applied in this group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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