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

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06008587

Collaborator

(none)

126

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Insufficiency	Device: AIRVO3 TM Other: Standard therapy	N/A

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 :

Identify the characteristics (etiologies) of responder patients (defined by a decrease in capnia and a failure to develop acidosis within two weeks of hospitalization)
Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients
Compare the evolution of respiratory rate between the two treatment groups
Compare the evolution of dyspnea between the two treatment groups
Compare the evolution of gas exchanges between the two treatment groups
Compare the length of stay between the two groups
Compare the evolution of patients comfort state in the two treatment groups

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
Bicarbonates [Up to 2 weeks]
HCO3- will be assessed from Day 0 to Day 15.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Major patient ≥ 18 years old
Medical diagnosis of Acute Respiratory Failure less than 24 hours
With partial pressure of carbon dioxide (PaCO2) ≥ 45 and pH > 7.35 for less than 24hours, 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

Exclusion Criteria:

Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies
Drug-induced Acute respiratory failure
Pneumothorax (X-ray pulmonary detachment)
Oxygen poisoning (Peripheral oxygen saturation (SpO2) ≥95%)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier de Cannes	Cannes	Alpes Maritime	France	06400
2	Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse	Toulon	Var	France	83100
3	Centre Hospitalier Princesse Grace	Monaco		Monaco	98000