Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-05-01

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

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Detailed Description

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Conditions

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Mechanical Ventilation Pressure High Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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titrate PEEP

individulaized PEEP starting 7cmH2O titrated to best static compliance (Cstat) ranging from 50 -100 cmH2O

Group Type EXPERIMENTAL

titated PEEP to best static compliance

Intervention Type OTHER

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

standard

standard PEEP of 5 cmH2O

Group Type ACTIVE_COMPARATOR

titated PEEP to best static compliance

Intervention Type OTHER

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

Interventions

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titated PEEP to best static compliance

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

Intervention Type OTHER

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes