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Recruiting NCT06168162

Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

No phase Interventional Mechanical Ventilation Pressure High Bariatric Surgery Candidate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: titated PEEP to best static compliance.
Who it may be relevant to
Registry conditions: Mechanical Ventilation Pressure High, Bariatric Surgery Candidate. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Individualized High Positive End-expiratory Pressure on Postoperative Pulmonary Rate in Laparoscopic Bariatric Surgeries

Overview

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

Interventions

  • Other titated PEEP to best static compliance
    the Intraoperative PEEP will be titrated to best static compliance for each patient

Primary outcome measures

  • postoperative pulmonary complication [Time frame: postoperative 10 days after surgery]
Secondary outcome measures (1)
  • Pulmonary functions test [Time frame: postoperative 1st , 3rd and 5th day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Ain shams university — Cairo

Identifiers

NCT: NCT06168162 · FMASU MD259/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗