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OpenTrials
Completed

NCT Number: NCT06600386

Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asklepieion Hospital of Voula

Athens, Attica, 16673, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alveolar recruitement

Other

PEEP after alveolar reruitment maneuvres

Standard PEEP

Other

PEEP 5 cmH2O

Primary outcomes

  1. Respiratory complications

    Time frame: 30 days

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

Secondary outcomes

  1. Pplat

    Time frame: intraoperatively

  2. SpO2

    Time frame: intraoperatively

  3. PCO2

    Time frame: intraoperatively

  4. PaO2/FiO2

    Time frame: intraoperatively

  5. Cdyn

    Time frame: intraoperatively

  6. Ppeak

    Time frame: intraoperatively

  7. MAP

    Time frame: intraoperatively

  8. heart rate

    Time frame: intraoperatively

  9. LUS score

    Time frame: Preoperatively and 30 minutes postoperatively

    Ultrasonographic findigs

Sponsors and collaborators

Lead sponsor

Asklepieion Voulas General Hospital

Other Gov

Collaborators

  • Ioanna Pikasi

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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