NCT01458444

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 830 (actual)
• Sponsor: Centre Chirurgical Marie Lannelongue · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Insufficiency

Interventions

Type	Name	Description
DEVICE	Non invasive ventilation (VNI)	BIPAP® vision
DEVICE	Non invasive ventilation	OPTIFLOW system

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-10-24
• Last updated: 2015-09-01

Locations

1 site across 1 country: France