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

Respiratory Insufficiency Clinical Trial

— OPTIFLOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458444
• Other study ID #: SC11-007
• Secondary ID: 2011-A00125-36
• Status: Completed
• Phase: N/A
• First received: October 21, 2011
• Last updated: August 30, 2015
• Start date: May 2011
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: Centre Chirurgical Marie Lannelongue
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• Non invasive ventilation (VNI)
BIPAP® vision
• Non invasive ventilation
OPTIFLOW system

Locations

Country	Name	City	State
France	Centre Chirurgical MarieLannelongue	Le Plessis Robinson	Ile de France

Sponsors (6)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue	Centre Hospitalier René Dubos, Hopital Jean Minjoz, Hopital Louis Pradel, University Hospital, Bordeaux, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of the ventilation system	Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown	One week	No
Secondary	Sensation of dyspnea		one week	No
Secondary	Skin tolerance and comfort		One week	Yes
Secondary	Evolution of hemodynamic and respiratory parameters		one week	No
Secondary	number of bronchoscopy performed during the patient's stay in Intensive Care Unit		one week	No
Secondary	number of postoperative pneumonia and antibiotic use		one week	Yes
Secondary	length of stay in intensive care		one week	No