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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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