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

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Device: AIRVO3 TM; Other: Standard therapy

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes Maritime
    • Cannes, Alpes Maritime, France, 06400
      • Centre Hospitalier de Cannes
  • Var
    • Toulon, Var, France, 83100
      • Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
• Monaco
  • Monaco, Monaco, 98000
    • Centre Hospitalier Princesse Grace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal High Flow therapy in association with the standard therapy	Device: AIRVO3 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.; Other: Standard 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.
Active Comparator: Standard therapy alone	Other: Standard 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Investigators: Study Director: Cécile MAINCENT, MD, Centre Hospitalier Princesse Grace

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): September 24, 2025
• Study Completion (Actual): September 24, 2025

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hypercapnia; Acute Respiratory Failure; Pneumology; Nasal High Flow; Respiratory non-acidosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Insufficiency; Hypercapnia; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2022-CHITS-012; 2022-A02641-42 (Other Identifier: ID-RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No