Back to resultsNIV Prevents Post-operative Respiratory Failure After Bariatric Surgery
Primary Purpose
Obesity, Postoperative Respiratory Distress
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non invasive ventilation (NIV)
Conventional Venturi Mask
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
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
- Asthma
- Severe renal dysfunction,
- cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class >II
Sites / Locations
- University of Campania Luigi Vanvitelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NIV Group
Control Group
Arm Description
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%.
In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m.
Outcomes
Primary Outcome Measures
Intensive care unit admission rate
The primary outcome was the evaluation of the ICU admission rate after NIV in postoperative management of obese patients
Blood oxygen saturation (SaPo2)
the evaluation of the oximetry values of obese patients after postoperative NIV adoption
Secondary Outcome Measures
Full Information
NCT ID
NCT04830475
First Posted
March 30, 2021
Last Updated
June 16, 2022
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT04830475
Brief Title
NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery
Official Title
Non-invasive Ventilation Prevents Post-operative Respiratory Failure in Patient Undergoing Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
February 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Postoperative Respiratory Distress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Retrospective Analysis
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIV Group
Arm Type
Experimental
Arm Description
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%.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
In the postoperative period, patients were offered VenturiMask with Fio2 60% at 15 l / m.
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation (NIV)
Intervention Description
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%.
Intervention Type
Device
Intervention Name(s)
Conventional Venturi Mask
Intervention Description
Patients were offered VenturiMask with Fio2 60% at 15 l / m.
Primary Outcome Measure Information:
Title
Intensive care unit admission rate
Description
The primary outcome was the evaluation of the ICU admission rate after NIV in postoperative management of obese patients
Time Frame
72 hours
Title
Blood oxygen saturation (SaPo2)
Description
the evaluation of the oximetry values of obese patients after postoperative NIV adoption
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Asthma
Severe renal dysfunction,
cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class >II
Facility Information:
Facility Name
University of Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
Learn more about this trial
NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery
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