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NCT Number: NCT06168162

Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

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

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Key information

Conditions

Mechanical Ventilation Pressure High Bariatric Surgery Candidate Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Location contact

FATHY tash, prof

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

titated PEEP to best static compliance

Other

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

Primary outcomes

  1. postoperative pulmonary complication

    Time frame: postoperative 10 days after surgery

    pneumonia-atelactasis-bronchospasm-respiratory failure

Secondary outcomes

  1. Pulmonary functions test

    Time frame: postoperative 1st , 3rd and 5th day

    This test includes these values :FVC (forced vital capacity ) FEV1( forced expiratory volume in one sec ) FEV1% and FVC%

Study contacts

Contact information is provided by the study sponsor or research team.

ghada sharafeldin, MSc

CONTACT

[email protected]

+201159296642

wessam selima, MD

CONTACT

[email protected]

+201001958858

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2023
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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