High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

Conditions
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Hypoxemic Acute Respiratory Failure

Intervention / Treatment
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* Device: Optiflow / Facial mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optiflow<br> | Device: Optiflow / Facial mask<br>* 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<br>|
| Experimental: Facial mask<br> | Device: Optiflow / Facial mask<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One hour and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale of satisfaction completed by the patient | To evaluate the tolerance of high flow oxygen therapy: satisfaction scale | at withdrawal of oxygen system | 
| Measure of pH, SatO2, PaO2, FiO2 | To evaluate hypoxia duration | 2 days | 
| Number of days of hospitalization | To evaluate the duration of hospitalization with the medical device | at day 28 | 
| Measure of PCO2 and respiratory frequency | To evaluate PCO2 and respiratory frequency at H+1 and J1 | One day | 
| Possibility of patient transfer in conventional service | To evaluate the reception in post reanimation if transfer under oxygen therapy | at day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Acute respiratory failure, High flow oxygen therapy