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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014