NCT04830475

NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Postoperative Respiratory Distress

Interventions

Type	Name	Description
DEVICE	Non invasive ventilation (NIV)	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	Conventional Venturi Mask	Patients were offered VenturiMask with Fio2 60% at 15 l / m.

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-31
• Completion: 2021-02-20
• First posted: 2021-04-05
• Last updated: 2022-06-23

Locations

1 site across 1 country: Italy