Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure

Study Overview
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Brief Summary
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The hypothesis is that Nasal High Flow therapy for patients with Hypercapnic Acute Respiratory Failure without acidosis, in addition to standard treatment would improve the care.

Detailed Description
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The aim of the PIRAHNA study is to compare patients treated with Nasal High Flow in association with conventional standard treatment versus patients treated only with conventional standard treatment. Primary objective : To demonstrate the therapeutic superiority of Nasal High Flow in hypercapnic Acute Respiratory Failure without acidosis, in combination with conventional standard treatment Secondary objectives : Identify the characteristics (etiologies) of responder patients (defined by a decrease in capnia and a failure to develop acidosis within two weeks of hospitalization) Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients Compare the evolution of respiratory rate between the two treatment groups Compare the evolution of dyspnea between the two treatment groups Compare the evolution of gas exchanges between the two treatment groups Compare the length of stay between the two groups Compare the evolution of patients comfort state in the two treatment groups

Official Title
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Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: AIRVO3 TM
* Other: Standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient ≥ 18 years old Medical diagnosis of Acute Respiratory Failure less than 24 hours With partial pressure of carbon dioxide (PaCO2) ≥ 45 and pH > 7.35 for less than 24hours, with no indication of Non-Invasive Ventilation (NIV) placement Underlying terrain of known or unknown chronic respiratory pathology (may be unknown at time of diagnosis) Examples : COPD, Bronchiectasis, Pulmonary fibrosis, asthma, sequelae pathologies … All etiologies (infectious, cardiac decompensation, trauma, etc.) Having given informed consent Patient under a social security scheme Exclusion Criteria: Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies Drug-induced Acute respiratory failure Pneumothorax (X-ray pulmonary detachment) Oxygen poisoning (Peripheral oxygen saturation (SpO2) ≥95%) Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVII) Pneumonia Tracheostomy Prior treatment with chronic or initiated NIV just prior to treatment (e.g. Intensive Care Unit) Respiratory Severity Criteria for Resuscitation Management Agitation or non-cooperation Pregnancy or breastfeeding Person participating in other biomedical research Any other reason that the investigator believes may interfere with the evaluation of the study objectives Person under judicial protection (guardianship, curatorship) Person deprived of liberty by a judicial or administrative decision

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal High Flow therapy in association with the standard therapy<br> | Device: AIRVO3 TM<br>* A device that provides high flows of heated and humidified respiratory gases to patient who breath spontaneously. Patients will be treated with the device up to 15 days or until the occurrence of respiratory acidosis defined by pH<7.35, whichever come first.<br>Other: Standard therapy<br>* Standard therapy depends on the acute respiratory failure etiology. Treatments will be administered at the investigator's discretion in accordance with the standard of care.<br>|
| Active Comparator: Standard therapy alone<br> | Other: Standard therapy<br>* Standard therapy depends on the acute respiratory failure etiology. Treatments will be administered at the investigator's discretion in accordance with the standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of the Nasal High Flow | Failure of the Nasal High Flow is defined by the occurrence of respiratory acidosis (pH<7.35) within 2 weeks after admission | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responding patients phenotype | Phenotype will be characterized by the presence of one or more of the following elements : obesity hypoventilation syndrome, chronic obstructive pulmonary disease (COPD) emphysema, thoracic enlargement, bronchiectasis. | At Day 30 after hospital discharge | 
| Etiology of acute respiratory failure | The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ... | Up to 2 weeks | 
| Respiratory rate | Respiratory rate will be recorded from Day 0 to Day 15, or until discharge (if less than 15 days). | Up to 2 weeks | 
| Dyspnea | Dyspnea will be assessed by the modified Borg scale rating of perceived exertion (RPE) from Day 0 to Day 15. The minimum value of the scale corresponding to no shortness of breath is 0 and the maximum value corresponding to dyspnea is 10. Higher score means a worse outcome. | Up to 2 weeks | 
| pH | pH will be assessed from Day 0 to Day 15. | Up to 2 weeks | 
| Partial Pressure of Carbon dioxide (PCO2) | PCO2 will be assessed from Day 0 to Day 15. | Up to 2 weeks | 
| Bicarbonates | HCO3- will be assessed from Day 0 to Day 15. | Up to 2 weeks | 
| pCO2 normalization time |  | Up to 2 weeks | 
| ROX index | ROX index will be performed from Day 0 to Day 15. | Up to 2 weeks | 
| Length of hospital stay | Duration will be recorded in days medically necessary in the pneumology department | Up to 2 weeks | 
| Comfort Visual Analogic Scale (VAS) | Patient's comfort will be assessed on a Visual Analogic Scale at Day 0, Day 7 and Day 15 or at hospital discharge. The minimum value of the scale, corresponding to no discomfort is 0 and the maximum value corresponding to the maximum discomfort, is 10. Higher score means a worse outcome. | Up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal High Flow, Acute Respiratory Failure, Respiratory non-acidosis, Pneumology, Hypercapnia