High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery (Optiflow)

This study is currently recruiting participants.
Verified October 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01617252
First received: June 8, 2012
Last updated: October 23, 2013
Last verified: October 2013

June 8, 2012
October 23, 2013
June 2011
June 2014   (final data collection date for primary outcome measure)
Measure of PaO2/FiO2 ratio [ Time Frame: One hour ]
The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.
Same as current
Complete list of historical versions of study NCT01617252 on ClinicalTrials.gov Archive Site
  • Scale of satisfaction completed by the patient [ Time Frame: at withdrawal of oxygen system ]
    To evaluate the tolerance of high flow oxygen therapy: satisfaction scale
  • Measure of pH, SatO2, PaO2, FiO2 [ Time Frame: 2 days ]
    To evaluate hypoxia duration
  • Number of days of hospitalization
    To evaluate the duration of hospitalization with the medical device
  • Measure of PCO2 and respiratory frequency [ Time Frame: One day ]
    To evaluate PCO2 and respiratory frequency at H+1 and J1
Same as current
Not Provided
Not Provided
 
High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Hypoxemic Acute Respiratory Failure
Device: Optiflow / Facial mask
J0: randomization (Optiflow® or facial mask), lung X-ray, kinesiotherapy H0 : clinical examination, blood gas, respiratory frequency H1 : clinical examination, blood gas, respiratory frequency H6 : clinical examination, blood gas J1: clinical examination, blood gas, respiratory frequency, lung X-ray, diaphragmatic echography, kinesiotherapy J2: clinical examination, blood gas, lung X-ray, kinesiotherapy Follow-up (until withdrawal of Optiflow or facial mask): clinical examination, blood gas, lung X-ray, kinesiotherapy
  • Experimental: Optiflow
    Intervention: Device: Optiflow / Facial mask
  • Experimental: Facial mask
    Intervention: Device: Optiflow / Facial mask
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
98
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient with indication of coronary artery bypass
  • Absence of preoperative respiratory failure
  • Hypoxia after extubation defined as SpO2 < 96% with Venturi mask 50% 8L/min
  • Age > 18 years
  • Signed informed consent

Exclusion Criteria:

  • Patients requiring an imminent intubation, in coma or respiratory exhaustion, in a state of shock or severe rhythm disorders
  • Pneumothorax
  • Ventricular arrhythmia
  • Pregnancy
  • Non controlled hyperalgia
Both
18 Years and older
No
Contact: Johanna NICOLET, Dr +33 2 40 16 51 22
France
 
NCT01617252
10/9-H
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP