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

NCT ID: NCT06008587

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2025-09-24

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

Conditions

Respiratory Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nasal High Flow therapy in association with the standard therapy

Group Type: EXPERIMENTAL

AIRVO3 TM

Intervention Type: DEVICE

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

Intervention Type: OTHER

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.

Standard therapy alone

Group Type: ACTIVE_COMPARATOR

Standard therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile MAINCENT, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Princesse Grace

Locations

Centre Hospitalier de Cannes

Cannes, Alpes Maritime, France

Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse

Toulon, Var, France

Centre Hospitalier Princesse Grace

Monaco, , Monaco

Countries

France; Monaco

Other Identifiers

2022-A02641-42

Identifier Type: OTHER

Identifier Source: secondary_id

2022-CHITS-012

Identifier Type: -

Identifier Source: org_study_id