NCT06600386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

September 14, 2024

Last Update Submit

February 17, 2025

Conditions

Postoperative Respiratory Complications

Keywords

Alveolar RecruitmentLaparoscopyIndvidualized PEEP

Outcome Measures

Primary Outcomes (1)

  • Respiratory complications

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

    30 days

Secondary Outcomes (9)

  • Pplat

    intraoperatively

  • SpO2

    intraoperatively

  • PCO2

    intraoperatively

  • PaO2/FiO2

    intraoperatively

  • Cdyn

    intraoperatively

  • +4 more secondary outcomes

Study Arms (2)

C-PEEP

ACTIVE COMPARATOR

PEEP is standard (5cmH2O)

Other: Standard PEEP

I-PEEP

ACTIVE COMPARATOR

PEEP is individualized following standard recruitment maneuvres

Other: Alveolar recruitement

Interventions

Alveolar recruitementOTHER

PEEP after alveolar reruitment maneuvres

I-PEEP
Standard PEEPOTHER

PEEP 5 cmH2O

C-PEEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III Laparoscopic abdominal surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asklepieion Hospital of Voula

Athens, Attica, 16673, Greece

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant Anesthesiologist

Study Record Dates

First Submitted

September 14, 2024

First Posted

September 19, 2024

Study Start

September 30, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

GR(1)