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Clinical Trials/NCT04830475
NCT04830475
Completed
Not Applicable

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

University of Campania "Luigi Vanvitelli"1 site in 1 country107 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Campania "Luigi Vanvitelli"
Enrollment
107
Locations
1
Primary Endpoint
Intensive care unit admission rate
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
February 20, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudio Gambardella

Clinical Professor

University of Campania "Luigi Vanvitelli"

Eligibility Criteria

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
  • Severe renal dysfunction,
  • cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class \>II

Outcomes

Primary Outcomes

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

Blood oxygen saturation (SaPo2)

Time Frame: 12 hours

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

Study Sites (1)

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