NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

Study Overview
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Brief Summary
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Postoperative non-invasive ventilation (NIV) has been proposed as an attractive strategy to reduce morbidity and improve postoperative outcomes in obese subjects undergoing general anesthesia. Bariatric patients present a peculiar negative feature; the increased body mass index (BMI) correlates with loss of perioperative functional residual capacity (FRC), expiratory reserve volume (ERV) and total lung capacity (TLC), decreased up to 50% of preoperative values. The aim of the current randomized trial is to evaluate the efficacy of NIV in post-anaesthesia care unit (PACU) in reducing post-extubation acute respiratory failure and the consequent admission in intensive care units (ICU) after BIBP in obese adult patients.

Official Title
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Non-invasive Ventilation Prevents Post-operative Respiratory Failure in Patient Undergoing Bariatric Surgery

Conditions
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Obesity, Postoperative Respiratory Distress

Intervention / Treatment
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* Device: Non invasive ventilation (NIV)
* Device: Conventional Venturi Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morbid Obesity Patients undergoing Biliointestinal Bypass (BIBP) Exclusion Criteria: Patients requiring emergency operation with rapid sequence induction Patients with suspected presence of difficult airway or pre-existing lung impairment Pregnancy Asthma Severe renal dysfunction, cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class >II

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Retrospective Analysis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIV Group<br>In poostoperative period, patients allocated in NIV Group fulfilled a 120-minute cycle of PSV + PEEP with full-face mask. Ventilation was performed with a Draeger Ventilator with the following basic settings: DeltaPInsp 10 mmHg + PEEP 5 mmHg + Fio2 60%. | Device: Non invasive ventilation (NIV)<br>* Patients allocated in NIV Group fulfilled a 120-minute cycle of PSV + PEEP with full-face mask. Ventilation was performed with a Draeger Ventilator with the following basic settings: DeltaPInsp 10 mmHg + PEEP 5 mmHg + Fio2 60%.<br>|
| Active Comparator: Control Group<br>In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m. | Device: Conventional Venturi Mask<br>* Patients were offered VenturiMask with Fio2 60% at 15 l / m.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care unit admission rate | The primary outcome was the evaluation of the ICU admission rate after NIV in postoperative management of obese patients | 72 hours | 
| Blood oxygen saturation (SaPo2) | the evaluation of the oximetry values of obese patients after postoperative NIV adoption | 12 hours |