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Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

A

Ain Shams University

Status

Enrolling

Conditions

Mechanical Ventilation Pressure High
Bariatric Surgery Candidate

Treatments

Other: titated PEEP to best static compliance

Study type

Interventional

Funder types

Other

Identifiers

NCT06168162
FMASU MD259/2023

Details and patient eligibility

About

Ventilation with low tidal volume and high PEEP (positive end expiratory pressure) has been shown to improve oxygenation in patients with ARDS (acute respiratory distress syndrome). In obese patients undergoing laparoscopic bariatric surgeries, the risk of postoperative pulmonary complications (PPCs) increases significantly with general anesthesia. Previous studies have shown that protective lung ventilation strategies could improve intraoperative oxygenation and lung mechanics.

In this study would compare the effect of optimum individualized high PEEP versus standard PEEP - on postoperative pulmonary complications

Enrollment

50 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients were eligible for participation if the met the following criteria

    • Age between 18 and 60 years old.
    • Body mass index > 40
    • Laparoscopic bariatric elective surgery under general anesthesia.
    • ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia) score ≥ 45 . ARISCAT score is a clinically practical seven-factor scoring system to assess the risk of a composite PPC.

Exclusion criteria

  • Previous lung surgery
  • ASA status III or IV.
  • Moderate to severe obstructive or restrictive lung disease .
  • Persistant intraoperative hemodynamic instability .
  • Need for postoperative mechanical ventilation

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

titrate PEEP
Experimental group
Description:
individulaized PEEP starting 7cmH2O titrated to best static compliance (Cstat) ranging from 50 -100 cmH2O
Treatment:
Other: titated PEEP to best static compliance
standard
Active Comparator group
Description:
standard PEEP of 5 cmH2O
Treatment:
Other: titated PEEP to best static compliance

Trial contacts and locations

1

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Central trial contact

ghada sharafeldin, MSc; wessam selima, MD

Data sourced from clinicaltrials.gov

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