NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

NCT04830475 | Completed

• 1 other identifier: NIV in obese
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Postoperative Respiratory Distress

Outcome Measures

Primary Outcomes (2)

• 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

• Blood oxygen saturation (SaPo2)

  the evaluation of the oximetry values of obese patients after postoperative NIV adoption

  12 hours

Study Arms (2)

NIV Group

EXPERIMENTAL

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%.

Device: Non invasive ventilation (NIV)

Control Group

ACTIVE COMPARATOR

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

Device: Conventional Venturi Mask

Interventions

Non invasive ventilation (NIV) DEVICE

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%.

NIV Group

Conventional Venturi Mask DEVICE

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Morbid Obesity
• Patients undergoing Biliointestinal Bypass (BIBP)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Retrospective Analysis

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 5, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 20, 2021
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

IT (1)