An interventional study of AIRVO3 TM and Standard therapy in Respiratory Insufficiency, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Not applicable, Interventional, and Treatment
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.
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 :
Exclusion Criteria:
Device: AIRVO3 TM · Other: Standard therapy
Other: Standard therapy
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.
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.
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
Time frame: Up to 2 weeks
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.
Time frame: 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, ...
Time frame: 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).
Time frame: 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.
Time frame: Up to 2 weeks
pH
pH will be assessed from Day 0 to Day 15.
Time frame: Up to 2 weeks
Partial Pressure of Carbon dioxide (PCO2)
PCO2 will be assessed from Day 0 to Day 15.
Time frame: Up to 2 weeks
Bicarbonates
HCO3- will be assessed from Day 0 to Day 15.
Time frame: Up to 2 weeks
pCO2 normalization time
Time frame: Up to 2 weeks
ROX index
ROX index will be performed from Day 0 to Day 15.
Time frame: Up to 2 weeks
Length of hospital stay
Duration will be recorded in days medically necessary in the pneumology department
Time frame: 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.
Time frame: Up to 2 weeks
This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer