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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01458444
Study type Interventional
Source Centre Chirurgical Marie Lannelongue
Contact
Status Completed
Phase N/A
Start date May 2011
Completion date January 2014

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