Status:
COMPLETED
BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery
Lead Sponsor:
Centre Chirurgical Marie Lannelongue
Collaborating Sponsors:
Hôpital NOVO
Hopital Jean Minjoz
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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 im...
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 n...
Eligibility Criteria
Inclusion
- 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
- Previous history of SAS
- Patient tracheotomy
- Comas non hypercapnic
- bradypnea
- Cardiac arrest
- Gastric Surgery recent
- Restlessness, lack of cooperation
- Nausea, vomiting
- Hemodynamic instability
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
830 Patients enrolled
Trial Details
Trial ID
NCT01458444
Start Date
May 1 2011
End Date
January 1 2014
Last Update
September 1 2015
Active Locations (1)
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1
Centre Chirurgical MarieLannelongue
Le Plessis-Robinson, Île-de-France Region, France, 92350