ClinicalTrials.gg
CompletedNCT06600386Updated Feb 19, 2025

Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications

A Phase 2 interventional study of Alveolar recruitement and Standard PEEP in Postoperative Respiratory Complications, sponsored by Asklepieion Voulas General Hospital. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Respiratory Complications

Keywords

  • Alveolar Recruitment
  • Laparoscopy
  • Indvidualized PEEP
03

In context

Lead sponsor

Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Laparoscopic abdominal surgery

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    C-PEEP

    PEEP is standard (5cmH2O)

    Other: Standard PEEP

  • Active comparator
    I-PEEP

    PEEP is individualized following standard recruitment maneuvres

    Other: Alveolar recruitement

Interventions

  • OtherAlveolar recruitement

    PEEP after alveolar reruitment maneuvres

  • OtherStandard PEEP

    PEEP 5 cmH2O

06

What researchers measure

Primary outcomes

  1. Respiratory complications

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

    Time frame: 30 days

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

    Ultrasonographic findigs

    Time frame: Preoperatively and 30 minutes postoperatively

07

Study locations

1 site
  • Asklepieion Hospital of Voula
    Athens, Attica 16673, Greece
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06600386
Lead sponsor
Asklepieion Voulas General Hospital
Collaborators
Ioanna Pikasi
Responsible party
Alexandros Makris (Senior Consultant Anesthesiologist, Asklepieion Voulas General Hospital) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 30, 2024
Primary completion
Feb 1, 2025
Completion
Feb 1, 2025
Last update
Feb 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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