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Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery

Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05781373
Enrollment
100
Registered
2023-03-23
Start date
2023-04-01
Completion date
2024-06-30
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication

Brief summary

In this prospective, randomized trial, including patients scheduled for a major open or laparoscopic abdominal surgery (duration \>2 hours) under general anesthesia , the investigators will compare 2 strategies of protective mechanical ventilation: a fixed intraoperative PEEP of 6 cmH2O and an individualized intraoperative PEEP according to the driving pressure.

Detailed description

Patients will be randomized into 2 groups: * Fixed PEEP group: will receive protective intraoperative mechanical ventilation: tidal volume: 6 ml/kg of PBW, recruitment maneuvers every immediately after tracheal intubation and every 2 hours and a fixed PEEP of 6 cmH2O * Individualized PEEP: protective mechanical ventilation with the same modality with an individualization of PEEP levels hourly in order to achieve the lowest driving pressure. PEEP levels will be adjusted after intubation and hourly by increasing or decreasing PEEP levels every 10 respiratory cycles. The primary outcome: incidence of post operative pulmonary complications during the first post operative days.

Interventions

PROCEDUREPeep individualization

Intraoperative Peep individualization in order to achieve the lowest driving pressure

Sponsors

Mongi Slim Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* BMI\<35, ARISCAT score \> 26, patients scheduled for major abdominal surgery

Exclusion criteria

* unplanned post operative ICU stay and mechanical ventilation

Design outcomes

Primary

MeasureTime frameDescription
incidence of pulmonary post operative complicationsfirst 7 post operative daysSpO2\< 92%, new chest Xray infiltrates, acute respiratory failure requiring intervention

Secondary

MeasureTime frameDescription
lung aeration score (LAS)day 1, day 3 and day 7 after surgeryassessment LAS with lung ultrasound minimum 0 maximum: 36 (worse outcome)

Contacts

Primary ContactMhamed Sami Mebazaa, full prof
msmebazaa@gmail.com0021622252589
Backup ContactAsma Ben Souissi, asso prof
bsouissiasma@gmail.com0021698336883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026