NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery

June 16, 2022 updated by: Claudio Gambardella, University of Campania "Luigi Vanvitelli"

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • University of Campania Luigi Vanvitelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIV Group
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)
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%.
Active Comparator: Control Group
In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m.
Device: Conventional Venturi Mask
Patients were offered VenturiMask with Fio2 60% at 15 l / m.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive care unit admission rate
Time Frame: 72 hours
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)
Time Frame: 12 hours
the evaluation of the oximetry values of obese patients after postoperative NIV adoption
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

February 20, 2021

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIV in obese

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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