Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications

Phase 2

Completed

• Conditions: Postoperative Respiratory Complications
• Interventions: Other: Alveolar recruitement; Other: Standard PEEP

• Registration Number: NCT06600386
• Lead Sponsor: Asklepieion Voulas General Hospital

Brief Summary

Patients ASA I-III, undergoing laparoscopic abdominal surgery will be randomly assigned, into one of two groups, namely group C-PEEP , that will be the control group ; and group I-PEEP, where alveolar recruitment maneuvres will take place in order to identify each patient\'s individualized optimal PEEP. All patients will receive a standardized anesthesia regimen. The lung ultrasound score will be evaluated in all patients in the PACU and then respiratory complications will be recorded on the 24th hour, 48th hour, 7th day and 30the day, postoperatively.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-14
• Study First Submitted QC: 2024-09-14
• Study First Posted: 2024-09-19
• Study Start: 2024-09-30
• Status Verified: 2025-02
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

ASA I-III Laparoscopic abdominal surgery

Exclusion Criteria

Severe kidney dysfunction Severe hepatic dysfunction Severe respiratory disease Severe cardiac disease Severe neuromuscular disease BMI>30 Severe intraoperative hemorrage Severe intraoperative hemodynamic instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-PEEP	Alveolar recruitement	PEEP is individualized following standard recruitment maneuvres
C-PEEP	Standard PEEP	PEEP is standard (5cmH2O)

Primary Outcome Measures

Name	Time	Method
Respiratory complications	30 days	Postoperative complications (atelectasis, bronchospasm, pneumonia, respiratory failure, ARDS, prolonged mechanical ventilations, reintubation, pleural infusion, COPD exacerbation)

Secondary Outcome Measures

Name	Time	Method
Pplat	intraoperatively
SpO2	intraoperatively
PCO2	intraoperatively
PaO2/FiO2	intraoperatively
Cdyn	intraoperatively
MAP	intraoperatively
Ppeak	intraoperatively
heart rate	intraoperatively
LUS score	Preoperatively and 30 minutes postoperatively	Ultrasonographic findigs

Trial Locations

Locations (1)

Asklepieion Hospital of Voula; 🇬🇷 Athens, Attica, Greece