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

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ClinicalTrials.gov Identifier: NCT01617252
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Hypoxemic Acute Respiratory Failure Device: Optiflow / Facial mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
Study Start Date : June 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Measure of PaO2/FiO2 ratio [ Time Frame: One hour and 24 hours ]
    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 :
  1. 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

  2. Measure of pH, SatO2, PaO2, FiO2 [ Time Frame: 2 days ]
    To evaluate hypoxia duration

  3. Number of days of hospitalization [ Time Frame: at day 28 ]
    To evaluate the duration of hospitalization with the medical device

  4. Measure of PCO2 and respiratory frequency [ Time Frame: One day ]
    To evaluate PCO2 and respiratory frequency at H+1 and J1

  5. Possibility of patient transfer in conventional service [ Time Frame: at day 5 ]
    To evaluate the reception in post reanimation if transfer under oxygen therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • Hemodynamic instability, low flow rate
  • Pneumothorax or hemothorax
  • Bleeding major, ischemic signs
  • Ventricular arrhythmia
  • Respiratory failure
  • Non controlled hyperalgia
  • Alteration of mental status
  • Cardiac surgery patients in post-operative valve surgery associated with coronary artery bypass surgery or isolated valve surgery
  • Pregnancy
  • Major under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617252


Locations
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France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01617252     History of Changes
Other Study ID Numbers: BRD/10/09-H
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Keywords provided by Nantes University Hospital:
Cardiac surgery
Acute respiratory failure
High flow oxygen therapy
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases