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

Primary Purpose

Hypoxemic Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Optiflow / Facial mask
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxemic Acute Respiratory Failure focused on measuring Cardiac surgery, Acute respiratory failure, High flow oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Optiflow

Facial mask

Arm Description

Outcomes

Primary Outcome Measures

Measure of PaO2/FiO2 ratio
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
To evaluate the tolerance of high flow oxygen therapy: satisfaction scale
Measure of pH, SatO2, PaO2, FiO2
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
To evaluate PCO2 and respiratory frequency at H+1 and J1
Possibility of patient transfer in conventional service
To evaluate the reception in post reanimation if transfer under oxygen therapy

Full Information

First Posted
June 8, 2012
Last Updated
October 2, 2018
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01617252
Brief Title
High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
Acronym
Optiflow
Official Title
High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemic Acute Respiratory Failure
Keywords
Cardiac surgery, Acute respiratory failure, High flow oxygen therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optiflow
Arm Type
Experimental
Arm Title
Facial mask
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Optiflow / Facial mask
Intervention Description
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 Measure Information:
Title
Measure of PaO2/FiO2 ratio
Description
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.
Time Frame
One hour and 24 hours
Secondary Outcome Measure Information:
Title
Scale of satisfaction completed by the patient
Description
To evaluate the tolerance of high flow oxygen therapy: satisfaction scale
Time Frame
at withdrawal of oxygen system
Title
Measure of pH, SatO2, PaO2, FiO2
Description
To evaluate hypoxia duration
Time Frame
2 days
Title
Number of days of hospitalization
Description
To evaluate the duration of hospitalization with the medical device
Time Frame
at day 28
Title
Measure of PCO2 and respiratory frequency
Description
To evaluate PCO2 and respiratory frequency at H+1 and J1
Time Frame
One day
Title
Possibility of patient transfer in conventional service
Description
To evaluate the reception in post reanimation if transfer under oxygen therapy
Time Frame
at day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France

12. IPD Sharing Statement

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High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

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