The Influence of Individualized Intraoperative PEEP After Alveolar Recruitment Maneuvres on the Incidence of Postoperative Respiratory Complications Following Laparoscopic Abdominal Surgery. A Prospective Randomized Controlled Study

Asklepieion Voulas General Hospital1 site in 1 country69 target enrollmentSeptember 30, 2024

ConditionsPostoperative Respiratory Complications

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Postoperative Respiratory Complications
Sponsor: Asklepieion Voulas General Hospital
Enrollment: 69
Locations: 1
Primary Endpoint: Respiratory complications
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 30, 2024

End Date

February 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Asklepieion Voulas General Hospital

Responsible Party

Principal Investigator

Alexandros Makris

Senior Consultant Anesthesiologist

Asklepieion Voulas General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Respiratory complications

Time Frame: 30 days

Postoperative complications (atelectasis, bronchospasm, pneumonia, respiratory failure, ARDS, prolonged mechanical ventilations, reintubation, pleural infusion, COPD exacerbation)