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
  Purpose

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.


Condition Intervention
Hypoxemic Acute Respiratory Failure
Device: Optiflow / Facial mask

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 98
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optiflow 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: Facial mask 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617252

Contacts
Contact: Johanna NICOLET, Dr +33 2 40 16 51 22

Locations
France
Nantes University Hospital Recruiting
Nantes, France
Contact: Johanna NICOLET, Dr    +33 2 40 16 51 22      
Principal Investigator: Johanna NICOLET, Dr         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01617252     History of Changes
Other Study ID Numbers: 10/9-H
Study First Received: June 8, 2012
Last Updated: October 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Cardiac surgery
Acute respiratory failure
High flow oxygen therapy

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on April 17, 2014