Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Respiratory Complications
• Intervention / Treatment: Other: Standard PEEP; Other: Alveolar recruitement

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 16673
      • Asklepieion Hospital of Voula

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: C-PEEP; PEEP is standard (5cmH2O)	Other: Standard PEEP; PEEP 5 cmH2O
Active Comparator: I-PEEP; PEEP is individualized following standard recruitment maneuvres	Other: Alveolar recruitement; PEEP after alveolar reruitment maneuvres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory complications	Postoperative complications (atelectasis, bronchospasm, pneumonia, respiratory failure, ARDS, prolonged mechanical ventilations, reintubation, pleural infusion, COPD exacerbation)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pplat		intraoperatively
SpO2		intraoperatively
PCO2		intraoperatively
PaO2/FiO2		intraoperatively
Cdyn		intraoperatively
Ppeak		intraoperatively
MAP		intraoperatively
heart rate		intraoperatively
LUS score	Ultrasonographic findigs	Preoperatively and 30 minutes postoperatively

Collaborators and Investigators

• Sponsor: Asklepieion Voulas General Hospital
• Collaborators: Ioanna Pikasi

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: September 14, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopy; Alveolar Recruitment; Indvidualized PEEP
• Other Study ID Numbers: 10542/22-05-2024/AP51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No