NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830475
• Other study ID #: NIV in obese
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 20, 2021

Study information

• Verified date: June 2022
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 20, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Postoperative Respiratory Distress
• Respiratory Insufficiency

Intervention

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%.
• Conventional Venturi Mask
Patients were offered VenturiMask with Fio2 60% at 15 l / m.

Locations

Country	Name	City	State
Italy	University of Campania Luigi Vanvitelli	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Blood oxygen saturation (SaPo2)	the evaluation of the oximetry values of obese patients after postoperative NIV adoption	12 hours