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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02641-42 | Other Identifier | ID-RCB number |
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Impossible to achieve inclusion goals, fewer patients in reality than expected
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal High Flow therapy in association with the standard therapy | Experimental |
| |
| Standard therapy alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIRVO3 TM | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Etiology of acute respiratory failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cécile MAINCENT, MD | Centre Hospitalier Princesse Grace | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Cannes | Cannes | Alpes Maritime | 06400 | France | ||
| Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard therapy | Other | 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. |
|
The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ... |
| Up to 2 weeks |
| 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 |
| 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 |
| pH | pH will be assessed from Day 0 to Day 15. | Up to 2 weeks |
| Partial Pressure of Carbon dioxide (PCO2) | PCO2 will be assessed from Day 0 to Day 15. | Up to 2 weeks |
| Bicarbonates | HCO3- will be assessed from Day 0 to Day 15. | Up to 2 weeks |
| pCO2 normalization time | Up to 2 weeks |
| ROX index | ROX index will be performed from Day 0 to Day 15. | Up to 2 weeks |
| Length of hospital stay | Duration will be recorded in days medically necessary in the pneumology department | Up to 2 weeks |
| 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 |
| Toulon |
| Var |
| 83100 |
| France |
| Centre Hospitalier Princesse Grace | Monaco | 98000 | Monaco |
| D013568 | Pathological Conditions, Signs and Symptoms |