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Clinical Trials/NCT06168162
NCT06168162
Recruiting
Not Applicable

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

Ain Shams University1 site in 1 country50 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation Pressure High
Sponsor
Ain Shams University
Enrollment
50
Locations
1
Primary Endpoint
postoperative pulmonary complication
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
May 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

postoperative pulmonary complication

Time Frame: postoperative 10 days after surgery

pneumonia-atelactasis-bronchospasm-respiratory failure

Secondary Outcomes

  • Pulmonary functions test(postoperative 1st , 3rd and 5th day)

Study Sites (1)

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