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

Respiratory Insufficiency Clinical Trial

— PIRAHNA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008587
• Other study ID #: 2022-CHITS-012
• Secondary ID: 2022-A02641-42
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: Magali CESANA
• Phone: 0494145525
• Email: magali.cesana[@]ch-toulon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier de Cannes	Cannes	Alpes Maritime
France	Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse	Toulon	Var
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Etiology of acute respiratory failure	The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ...	Up to 2 weeks
Secondary	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
Secondary	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
Secondary	pH	pH will be assessed from Day 0 to Day 15.	Up to 2 weeks
Secondary	Partial Pressure of Carbon dioxide (PCO2)	PCO2 will be assessed from Day 0 to Day 15.	Up to 2 weeks
Secondary	Bicarbonates	HCO3- will be assessed from Day 0 to Day 15.	Up to 2 weeks
Secondary	pCO2 normalization time		Up to 2 weeks
Secondary	ROX index	ROX index will be performed from Day 0 to Day 15.	Up to 2 weeks
Secondary	Length of hospital stay	Duration will be recorded in days medically necessary in the pneumology department	Up to 2 weeks
Secondary	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