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

August 30, 2015 updated by: Centre Chirurgical Marie Lannelongue

Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

830

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

    • Ile de France
      • Le Plessis Robinson, Ile de France, France, 92350
        • Centre Chirurgical MarieLannelongue

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:

  • 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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: BIPAP
Non invasive ventilation (VNI) by BIPAP® vision
BIPAP® vision
EXPERIMENTAL: OPTIFLOW
OPTIFLOW system
OPTIFLOW system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure of the ventilation system
Time Frame: One week
Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown
One week

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensation of dyspnea
Time Frame: one week
one week
Skin tolerance and comfort
Time Frame: One week
One week
Evolution of hemodynamic and respiratory parameters
Time Frame: one week
one week
number of bronchoscopy performed during the patient's stay in Intensive Care Unit
Time Frame: one week
one week
number of postoperative pneumonia and antibiotic use
Time Frame: one week
one week
length of stay in intensive care
Time Frame: one week
one week

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

May 1, 2011

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (ESTIMATE)

October 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 30, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • SC11-007
  • 2011-A00125-36 (OTHER: ANSM)

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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