BIPAP Vision Versus OPTIFLOW System Comparison in Acute R... | NCT01458444

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

NCT01458444

Sponsor

Centre Chirurgical Marie Lannelongue

Status

Completed

Last Update Posted

Sep 1, 2015Estimated

Enrollment

830Actual

Phase

Not Applicable

Conditions

Respiratory Insufficiency

Interventions

Non invasive ventilation (VNI)
Non invasive ventilation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-A00125-36	Other Identifier	ANSM

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Oct 21, 2011

First Submission Date that Met QC Criteria

Oct 21, 2011

First Posted Date

Oct 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Name	Class
Hôpital NOVO	OTHER
Hopital Jean Minjoz	OTHER
University Hospital, Bordeaux	OTHER
University Hospital, Clermont-Ferrand

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

830Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIPAP	Active Comparator	Non invasive ventilation (VNI) by BIPAP® vision	Device: Non invasive ventilation (VNI)
OPTIFLOW	Experimental	OPTIFLOW system	Device: Non invasive ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non invasive ventilation (VNI)	Device	BIPAP® vision	BIPAP
Non invasive ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Sensation of dyspnea		one week
Skin tolerance and comfort		One week
Evolution of hemodynamic and respiratory parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François STEPHAN, MD	CCML	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Chirurgical MarieLannelongue		Le Plessis-Robinson	Île-de-France Region	92350	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25980660	Derived	Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy