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

Intermunicipal Hospital Center Toulon

Status: Terminated

Conditions: Respiratory Insufficiency

Treatments: Other: Standard therapy; Device: AIRVO3 TM

Study type: Interventional

Funder types: Other

Identifiers

NCT06008587

2022-CHITS-012

2022-A02641-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Nasal High Flow therapy in association with the standard therapy

Experimental group

Treatment:

Device: AIRVO3 TM

Other: Standard therapy

Standard therapy alone

Active Comparator group

Treatment:

Other: Standard therapy