Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
- Conditions
- Respiratory Insufficiency
- Interventions
- Device: AIRVO3 TMOther: Standard therapy
- Registration Number
- NCT06008587
- Lead Sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nasal High Flow therapy in association with the standard therapy Standard therapy - Standard therapy alone Standard therapy - Nasal High Flow therapy in association with the standard therapy AIRVO3 TM -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.pCO2 normalization time Up to 2 weeks 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.
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
pH Up to 2 weeks pH will be assessed from Day 0 to Day 15.
Etiology of acute respiratory failure Up to 2 weeks The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ...
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.
Trial Locations
- Locations (3)
Centre Hospitalier de Cannes
🇫🇷Cannes, Alpes Maritime, France
Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
🇫🇷Toulon, Var, France
Centre Hospitalier Princesse Grace
🇲🇨Monaco, Monaco