Respiratory InsufficiencyPIRAHNANCT06008587
Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
A study testing AIRVO3 TM and Standard therapy in people with Respiratory Insufficiency, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- AIRVO3 TM and Standard therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 27 Feb 2024to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 with a free interval of 3 months
Who cannot join
- Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies
- Drug-induced Acute respiratory failure
- Pneumothorax (X-ray pulmonary detachment)
- Oxygen poisoning. In this case, PaCO2 will be asset again later with the purpose to include after oxygenotherapy decrease for a target SpO2 of 92% maximum
- Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVII) Pneumonia
- Tracheostomy
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Centre Hospitalier de Cannes
Cannes, Alpes Maritime, 06400
Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
Toulon, Var, 83100
About this study
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.
Read the 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 :
- Identify the characteristics (etiologies) of responder patients (defined by a decrease in capnia and a failure to develop acidosis within two weeks of hospitalization)
- Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients
- Compare the evolution of respiratory rate between the two treatment groups
- Compare the evolution of dyspnea between the two treatment groups
- Compare the evolution of gas exchanges between the two treatment groups
- Compare the length of stay between the two groups
- Compare the evolution of patients comfort state in the two treatment groups
- Conditions
- Respiratory Insufficiency
- Being tested
- AIRVO3 TM, Standard therapy
- Keywords
- Nasal High Flow, Acute Respiratory Failure, Respiratory non-acidosis, Pneumology, Hypercapnia
- Medical subject headings
- Respiratory Insufficiency, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRVO3 TMDevice
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.
Standard therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nasal High Flow therapy in association with the standard therapy | Experimental | Not described Receives: Device: AIRVO3 TM; Other: Standard therapy |
| Standard therapy alone | Active comparator | Not described Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 weeks
Secondary outcomes (11)
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.
Measured: At Day 30 after hospital discharge
Etiology of acute respiratory failure
The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ...
Measured: 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).
Measured: 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.
Measured: Up to 2 weeks
pH
pH will be assessed from Day 0 to Day 15.
Measured: Up to 2 weeks
Partial Pressure of Carbon dioxide (PCO2)
PCO2 will be assessed from Day 0 to Day 15.
Measured: Up to 2 weeks
Bicarbonates
HCO3- will be assessed from Day 0 to Day 15.
Measured: Up to 2 weeks
pCO2 normalization time
Measured: Up to 2 weeks
ROX index
ROX index will be performed from Day 0 to Day 15.
Measured: Up to 2 weeks
Length of hospital stay
Duration will be recorded in days medically necessary in the pneumology department
Measured: 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.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start27 Feb 2024
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Why it stopped: Impossible to achieve inclusion goals, fewer patients in reality than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile MAINCENT, MD, Study director, Centre Hospitalier Princesse Grace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008587
- Sponsor's protocol ID
- 2022-CHITS-012
- Other IDs
- 2022-A02641-42
- Acronym
- PIRAHNA
- Status last verified
- Nov 2025
- First submitted
- 11 Aug 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT06008587
- Acronym / sponsor ID
- PIRAHNA / 2022-CHITS-012
- Conditions
- Respiratory Insufficiency
- Keywords
- Nasal High Flow, Acute Respiratory Failure, Respiratory non-acidosis, Pneumology, Hypercapnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Impossible to achieve inclusion goals, fewer patients in reality than expected
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Identify the characteristics (etiologies) of responder patients (defined by a decrease in capnia and a failure to develop acidosis within two weeks of hospitalization)
- Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients
- Compare the evolution of respiratory rate between the two treatment groups
- Compare the evolution of dyspnea between the two treatment groups
- Compare the evolution of gas exchanges between the two treatment groups
- Compare the length of stay between the two groups
- Compare the evolution of patients comfort state in the two treatment groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal High Flow therapy in association with the standard therapy | Experimental | Device: AIRVO3 TM, Other: Standard therapy |
| Standard therapy alone | Active comparator | Other: Standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.)
Key exclusion criteria (14 listed)
- Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies
- Drug-induced Acute respiratory failure
- Pneumothorax (X-ray pulmonary detachment)
- Oxygen poisoning. In this case, PaCO2 will be asset again later with the purpose to include after oxygenotherapy decrease for a target SpO2 of 92% maximum
- Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVII) Pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIRVO3 TMA 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. | Device | Nasal High Flow therapy in association with the standard therapy |
| Standard therapyStandard therapy depends on the acute respiratory failure etiology. Treatments will be administered at the investigator's discretion in accordance with the standard of care. | Other | Nasal High Flow therapy in association with the standard therapy, Standard therapy alone |
Primary outcome
Failure of the Nasal High Flow
Time frame: 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
11 secondary outcomes
Responding patients phenotype
Time frame: At Day 30 after hospital discharge
Etiology of acute respiratory failure
Time frame: Up to 2 weeks
Respiratory rate
Time frame: Up to 2 weeks
Dyspnea
Time frame: Up to 2 weeks
pH
Time frame: Up to 2 weeks
Partial Pressure of Carbon dioxide (PCO2)
Time frame: Up to 2 weeks
Bicarbonates
Time frame: Up to 2 weeks
pCO2 normalization time
Time frame: Up to 2 weeks
ROX index
Time frame: Up to 2 weeks
Length of hospital stay
Time frame: Up to 2 weeks
Comfort Visual Analogic Scale (VAS)
Time frame: Up to 2 weeks
Results and safety
The study was stopped early (reason given: Impossible to achieve inclusion goals, fewer patients in reality than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile MAINCENT, MD study director
Centre Hospitalier Princesse Grace
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIRVO3 TM and Standard therapy in people with Respiratory Insufficiency, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Impossible to achieve inclusion goals, fewer patients in reality than expected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of the Nasal High Flow (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.