NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

Not Applicable

Completed

• Conditions: Postoperative Respiratory Distress; Obesity
• Interventions: Device: Conventional Venturi Mask; Device: Non invasive ventilation (NIV)

• Registration Number: NCT04830475
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-02-20
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Conventional Venturi Mask	In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m.
NIV Group	Non invasive ventilation (NIV)	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%.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy