Respiratory Insufficiency
Conditions
Keywords
Nasal High Flow, Acute Respiratory Failure, Respiratory non-acidosis, Pneumology, Hypercapnia
Brief summary
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
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 : 1. Identify the characteristics (etiologies) of responder patients (defined by a decrease in capnia and a failure to develop acidosis within two weeks of hospitalization) 2. Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients 3. Compare the evolution of respiratory rate between the two treatment groups 4. Compare the evolution of dyspnea between the two treatment groups 5. Compare the evolution of gas exchanges between the two treatment groups 6. Compare the length of stay between the two groups 7. Compare the evolution of patients comfort state in the two treatment groups
Interventions
DEVICEAIRVO3 TM
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.
OTHERStandard therapy
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.
Sponsors
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Major patient ≥ 18 years old * Medical diagnosis of Acute Respiratory Failure less than 48 hours * With partial pressure of carbon dioxide (PaCO2) \> 45 and pH \> 7.35 for less than 48 hours, 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 * Possibility to include a patient having already been included in the study but suffering from a new episode of hypercapnic non acidic Acute Respiratory Failure with a free interval of 3 months
Exclusion criteria
* Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies * Drug-induced Acute respiratory failure * Pneumothorax (X-ray pulmonary detachment) * Oxygen poisoning. In this case, PaCO2 will be asset again later with the purpose to include after oxygenotherapy decrease for a target SpO2 of 92% maximum * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure of the Nasal High Flow | Up to 2 weeks | Failure of the Nasal High Flow is defined by the occurrence of respiratory acidosis (pH\<7.35) within 2 weeks after admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Etiology of acute respiratory failure | Up to 2 weeks | The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ... |
| Respiratory rate | Up to 2 weeks | Respiratory rate will be recorded from Day 0 to Day 15, or until discharge (if less than 15 days). |
| Dyspnea | Up to 2 weeks | 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. |
| pH | Up to 2 weeks | pH will be assessed from Day 0 to Day 15. |
| Partial Pressure of Carbon dioxide (PCO2) | Up to 2 weeks | PCO2 will be assessed from Day 0 to Day 15. |
| Responding patients phenotype | At Day 30 after hospital discharge | 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. |
| pCO2 normalization time | Up to 2 weeks | — |
| ROX index | Up to 2 weeks | ROX index will be performed from Day 0 to Day 15. |
| Length of hospital stay | Up to 2 weeks | Duration will be recorded in days medically necessary in the pneumology department |
| Comfort Visual Analogic Scale (VAS) | Up to 2 weeks | 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. |
| Bicarbonates | Up to 2 weeks | HCO3- will be assessed from Day 0 to Day 15. |
Countries
France, Monaco
Outcome results
None listed