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

Not Applicable

Completed

• Conditions: Respiratory Insufficiency
• Interventions: Device: Non invasive ventilation; Device: Non invasive ventilation (VNI)

• Registration Number: NCT01458444
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-21
• Study First Posted: 2011-10-24
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-30
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 830

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPTIFLOW	Non invasive ventilation	OPTIFLOW system
BIPAP	Non invasive ventilation (VNI)	Non invasive ventilation (VNI) by BIPAP® vision

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Chirurgical MarieLannelongue; 🇫🇷 Le Plessis Robinson, Ile de France, France