NCT01458444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
830

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

2.7 years

First QC Date

October 21, 2011

Last Update Submit

August 30, 2015

Conditions

Respiratory Insufficiency

Keywords

Respiratory InsufficiencyCardiothoracic SurgeryVentilation system

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Sensation of dyspnea

    one week

  • Skin tolerance and comfort

    One week

  • Evolution of hemodynamic and respiratory parameters

    one week

  • number of bronchoscopy performed during the patient's stay in Intensive Care Unit

    one week

  • number of postoperative pneumonia and antibiotic use

    one week

  • +1 more secondary outcomes

Study Arms (2)

BIPAP

ACTIVE COMPARATOR

Non invasive ventilation (VNI) by BIPAP® vision

Device: Non invasive ventilation (VNI)

OPTIFLOW

EXPERIMENTAL

OPTIFLOW system

Device: Non invasive ventilation

Interventions

Non invasive ventilation (VNI)DEVICE

BIPAP® vision

BIPAP
Non invasive ventilationDEVICE

OPTIFLOW system

OPTIFLOW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous history of SAS
  • Patient tracheotomy
  • Comas non hypercapnic
  • bradypnea
  • Cardiac arrest
  • Gastric Surgery recent
  • Restlessness, lack of cooperation
  • Nausea, vomiting
  • Hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Chirurgical MarieLannelongue

Le Plessis-Robinson, Île-de-France Region, 92350, France

Location

Related Publications (1)

  • 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.

    PMID: 25980660DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • François STEPHAN, MD

    CCML

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 24, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

FR(1)