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Completed

NCT Number: NCT01458444

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Chirurgical MarieLannelongue

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non invasive ventilation (VNI)

Device

BIPAP® vision

Non invasive ventilation

Device

OPTIFLOW system

Primary outcomes

  1. Failure of the ventilation system

    Time frame: One week

    Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown

Secondary outcomes

  1. Sensation of dyspnea

    Time frame: one week

  2. Skin tolerance and comfort

    Time frame: One week

  3. Evolution of hemodynamic and respiratory parameters

    Time frame: one week

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

    Time frame: one week

  5. number of postoperative pneumonia and antibiotic use

    Time frame: one week

  6. length of stay in intensive care

    Time frame: one week

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Collaborators

  • Hopital Jean Minjoz
  • Hopital Louis Pradel
  • Hôpital NOVO
  • University Hospital, Bordeaux
  • University Hospital, Clermont-Ferrand

Registry information

Official study title

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

Acronym: OPTIFLOW

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2011
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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