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BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery (OPTIFLOW)

Primary Purpose

Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non invasive ventilation (VNI)
Non invasive ventilation
Sponsored by
Centre Chirurgical Marie Lannelongue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency, Cardiothoracic Surgery, Ventilation system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients after cardiac/thoracic surgery with acute respiratory failure defined by the presence of the following criteria:

    • report PaO2/FiO2 <300
    • Respiratory rate> 25 for at least 2 hours
    • Getting involved accessory respiratory muscles
    • paradoxical breathing Or

  • In immediate after extubation, the patient will be eligible if present in the withdrawal test:

    • SaO2 <90% in 12 L of O2 during a trial of spontaneous ventilation tube on
    • PaO2 <10 kPa at a FiO2 ≥ 50% during a VS trial + pressure support
    • The presence of a risk factor: Obesity (BMI> 30), FEVG <40%, Failed extubation prior, stridor

Exclusion Criteria:

  • Previous history of SAS
  • Patient tracheotomy
  • Comas non hypercapnic
  • bradypnea
  • Cardiac arrest
  • Gastric Surgery recent
  • Restlessness, lack of cooperation
  • Nausea, vomiting
  • Hemodynamic instability

Sites / Locations

  • Centre Chirurgical MarieLannelongue

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BIPAP

OPTIFLOW

Arm Description

Non invasive ventilation (VNI) by BIPAP® vision

OPTIFLOW system

Outcomes

Primary Outcome Measures

Failure of the ventilation system
Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown

Secondary Outcome Measures

Sensation of dyspnea
Skin tolerance and comfort
Evolution of hemodynamic and respiratory parameters
number of bronchoscopy performed during the patient's stay in Intensive Care Unit
number of postoperative pneumonia and antibiotic use
length of stay in intensive care

Full Information

First Posted
October 21, 2011
Last Updated
August 30, 2015
Sponsor
Centre Chirurgical Marie Lannelongue
Collaborators
Hôpital NOVO, Hopital Jean Minjoz, University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Hopital Louis Pradel
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1. Study Identification

Unique Protocol Identification Number
NCT01458444
Brief Title
BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery
Acronym
OPTIFLOW
Official Title
Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
Collaborators
Hôpital NOVO, Hopital Jean Minjoz, University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Hopital Louis Pradel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the use, in the immediate postoperative period, should lead to define the role of each technique and lead to a optimal rationalization of patients management with acute respiratory failure after surgery.
Detailed Description
Main objective: to determine, if the initiation of OPTIFLOW™ system immediate after cardio/ thoracic surgery with acute respiratory failure or immediate after post extubation in patients at risk, is not less than the start a VNI per BIPAP Vision ®system. In terms of reintubation rates, refusal to continue the technique, or switch to another technique proposed. Secondary objectives: To assess changes in the sensation of dyspnea To analyze the skin tolerance and the comfort in this population To analyze the evolution of hemodynamic and respiratory parameters To compare the number of bronchoscopy performed during the patient's stay in intensive care unit Assess the number of postoperative pneumonia and antibiotic consumption To determine whether the initiation of any treatment changes in the immediate postoperative length of stay in intensive care and comprehensive.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Respiratory Insufficiency, Cardiothoracic Surgery, Ventilation system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
830 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIPAP
Arm Type
Active Comparator
Arm Description
Non invasive ventilation (VNI) by BIPAP® vision
Arm Title
OPTIFLOW
Arm Type
Experimental
Arm Description
OPTIFLOW system
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation (VNI)
Intervention Description
BIPAP® vision
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation
Intervention Description
OPTIFLOW system
Primary Outcome Measure Information:
Title
Failure of the ventilation system
Description
Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown
Time Frame
One week
Secondary Outcome Measure Information:
Title
Sensation of dyspnea
Time Frame
one week
Title
Skin tolerance and comfort
Time Frame
One week
Title
Evolution of hemodynamic and respiratory parameters
Time Frame
one week
Title
number of bronchoscopy performed during the patient's stay in Intensive Care Unit
Time Frame
one week
Title
number of postoperative pneumonia and antibiotic use
Time Frame
one week
Title
length of stay in intensive care
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients after cardiac/thoracic surgery with acute respiratory failure defined by the presence of the following criteria: report PaO2/FiO2 <300 Respiratory rate> 25 for at least 2 hours Getting involved accessory respiratory muscles paradoxical breathing Or In immediate after extubation, the patient will be eligible if present in the withdrawal test: SaO2 <90% in 12 L of O2 during a trial of spontaneous ventilation tube on PaO2 <10 kPa at a FiO2 ≥ 50% during a VS trial + pressure support The presence of a risk factor: Obesity (BMI> 30), FEVG <40%, Failed extubation prior, stridor Exclusion Criteria: Previous history of SAS Patient tracheotomy Comas non hypercapnic bradypnea Cardiac arrest Gastric Surgery recent Restlessness, lack of cooperation Nausea, vomiting Hemodynamic instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François STEPHAN, MD
Organizational Affiliation
CCML
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Chirurgical MarieLannelongue
City
Le Plessis Robinson
State/Province
Ile de France
ZIP/Postal Code
92350
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25980660
Citation
Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
Results Reference
derived

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BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery

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