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

NCT05494255 | Completed

• 1 other identifier: 2022/1066
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Atelectasis

Outcome Measures

Primary Outcomes (1)

• Comparison of the pre-extubation LUS scores (T3)

  Lung ultrasound will be applied in each group to observe the lungs' condition (atelectasis,consolidation...) and understand the effect of a "single" recruitment maneuver. To obtain LUS score; each lobe is examined on 6 different areas which will be scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).

  Up to 4 hours

Secondary Outcomes (7)

• Comparison of recovery room LUS scores (T4)

  Up to 4.5 hours

• Comparison of recovery room PaO2

  Up to 4.5 hours

• The effect of deltaLUS (T3-T2) on oxygenation

  Up to 4.5 hours

• Length of stay in post anesthesia care unit (PACU)

  Up to 4 hours

• Length of stay in hospital

  Up to 2 weeks

Study Arms (2)

Group RM

ACTIVE COMPARATOR

One single recruitment maneuver will be applied in this group at the end of the surgery and before the extubation

Other: Recruitment maneuver

Group NoRM

NO INTERVENTION

Usual care will be applied in this group

Interventions

Recruitment maneuver OTHER

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 RM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Lecturer, Medical Doctor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: August 11, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 4, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

TU (1)