Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Study Overview
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Brief Summary
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The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.

Official Title
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Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Other: Oxygen therapy delivery systems


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient hospitalized in the intensive care unit of Nantes University Hospital Signed informed consent Patient with not hypercapnic acute hypoxemic respiratory failure Immunocompetent and immunodeficient patient Exclusion Criteria: Age < 18 years Pregnancy Contra-indication to non invasive ventilation Allergy to xylocaine Coagulation troubles Tracheotomized patient Urgent indication to intubation Hypercapnic acute respiratory failure Acute pulmonary edema Face or nose malformation

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VNI/Optiflow, Immunodeficient patients<br>VNI = non invasive ventilation | Other: Oxygen therapy delivery systems<br>* T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2<br>|
| Experimental: Optiflow/VNI, Immunodeficient patients<br>VNI = non invasive ventilation | Other: Oxygen therapy delivery systems<br>* T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2<br>|
| Experimental: Ospal/Optiflow, Immunocompetent patients<br> | Other: Oxygen therapy delivery systems<br>* T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2<br>|
| Experimental: Optiflow/Ospal, Immunocompetent patients<br> | Other: Oxygen therapy delivery systems<br>* T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcul of the ratio PaO2/FiO2 | The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation) by calculating the ratio PaO2/FiO2 | one hour after each system used | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events | The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system: number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events impact on work of breathing: measure of respiratory frequency and blood gas measure of positive and expiratory pressure |  | 
| measure of respiratory frequency and blood gas | The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system: number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events impact on work of breathing: measure of respiratory frequency and blood gas measure of positive and expiratory pressure |  | 
| measure of positive and expiratory pressure | The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system: number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events impact on work of breathing: measure of respiratory frequency and blood gas measure of positive and expiratory pressure |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute respiratory failure, Oxygen therapy delivery systems, Non invasive ventilation, High concentration mask, Hypoxemic pneumonia