Clinical trial NCT06008587: Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
Official title: Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: Nasal High Flow
Acute Respiratory Failure
Respiratory non-acidosis
Pneumology
Hypercapnia
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Exclusion Criteria:

* Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies
* Drug-induced Acute respiratory failure
* Pneumothorax (X-ray pulmonary detachment)
* Oxygen poisoning
* 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

Primary outcomes:
measure: Failure of the Nasal High Flow
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Responding patients phenotype
timeFrame: At Day 30 after hospital discharge
measure: Etiology of acute respiratory failure
timeFrame: Up to 2 weeks
measure: Respiratory rate
timeFrame: Up to 2 weeks
measure: Dyspnea
timeFrame: Up to 2 weeks
measure: pH
timeFrame: Up to 2 weeks
measure: Partial Pressure of Carbon dioxide (PCO2)
timeFrame: Up to 2 weeks
measure: Bicarbonates
timeFrame: Up to 2 weeks
measure: pCO2 normalization time
timeFrame: Up to 2 weeks
measure: ROX index
timeFrame: Up to 2 weeks
measure: Length of hospital stay
timeFrame: Up to 2 weeks
measure: Comfort Visual Analogic Scale (VAS)
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Cannes
country: France
facility: Centre Hospitalier de Cannes
state: Alpes Maritime
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
state: Var
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: Centre Hospitalier Princesse Grace
name: Cécile MAINCENT, MD
role: STUDY_DIRECTOR
References: