Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

Study Overview
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Brief Summary
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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

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

Conditions
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Mechanical Ventilation Pressure High, Bariatric Surgery Candidate

Intervention / Treatment
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* Other: titated PEEP to best static compliance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: titrate PEEP<br>individulaized PEEP starting 7cmH2O titrated to best static compliance (Cstat) ranging from 50 -100 cmH2O | Other: titated PEEP to best static compliance<br>* the Intraoperative PEEP will be titrated to best static compliance for each patient<br>|
| Active Comparator: standard<br>standard PEEP of 5 cmH2O | Other: titated PEEP to best static compliance<br>* the Intraoperative PEEP will be titrated to best static compliance for each patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pulmonary complication | pneumonia-atelactasis-bronchospasm-respiratory failure | postoperative 10 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary functions test | This test includes these values :FVC (forced vital capacity ) FEV1( forced expiratory volume in one sec ) FEV1% and FVC% | postoperative 1st , 3rd and 5th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventilation