Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications

NCT ID: NCT06600386

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-02-01

Brief Summary

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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

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Conditions

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Postoperative Respiratory Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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C-PEEP

PEEP is standard (5cmH2O)

Group Type ACTIVE_COMPARATOR

Standard PEEP

Intervention Type OTHER

PEEP 5 cmH2O

I-PEEP

PEEP is individualized following standard recruitment maneuvres

Group Type ACTIVE_COMPARATOR

Alveolar recruitement

Intervention Type OTHER

PEEP after alveolar reruitment maneuvres

Interventions

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Alveolar recruitement

PEEP after alveolar reruitment maneuvres

Intervention Type OTHER

Standard PEEP

PEEP 5 cmH2O

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ioanna Pikasi

UNKNOWN

Sponsor Role collaborator

Asklepieion Voulas General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alexandros Makris

Senior Consultant Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asklepieion Hospital of Voula

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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10542/22-05-2024/AP51

Identifier Type: -

Identifier Source: org_study_id

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