NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04830475

Enrollment

107

Registered

2021-04-05

Start date

2019-01-01

Completion date

2021-02-20

Last updated

2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Postoperative Respiratory Distress

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.

Interventions

DEVICEConventional Venturi Mask

Patients were offered VenturiMask with Fio2 60% at 15 l / m.

DEVICENon 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%.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Retrospective Analysis

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026