NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Postoperative Respiratory Distress; Obesity

Treatments: Device: Non invasive ventilation (NIV); Device: Conventional Venturi Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04830475

NIV in obese

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

NIV Group

Experimental group

Description:

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%.

Treatment:

Device: Non invasive ventilation (NIV)

Control Group

Active Comparator group

Description:

In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m.

Treatment:

Device: Conventional Venturi Mask