Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure (PIRAHNA)

November 19, 2025 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Alpes Maritime
      • Cannes, Alpes Maritime, France, 06400
        • Centre Hospitalier de Cannes
    • Var
      • Toulon, Var, France, 83100
        • Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
  • Monaco
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 with a free interval of 3 months

Exclusion Criteria:

  • 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
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nasal High Flow therapy in association with the standard therapy
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.
Active Comparator: Standard therapy alone
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Responding patients phenotype
Time Frame: 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.
At Day 30 after hospital discharge
Etiology of acute respiratory failure
Time Frame: Up to 2 weeks
The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ...
Up to 2 weeks
Respiratory rate
Time Frame: Up to 2 weeks
Respiratory rate will be recorded from Day 0 to Day 15, or until discharge (if less than 15 days).
Up to 2 weeks
Dyspnea
Time Frame: 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.
Up to 2 weeks
pH
Time Frame: Up to 2 weeks
pH will be assessed from Day 0 to Day 15.
Up to 2 weeks
Partial Pressure of Carbon dioxide (PCO2)
Time Frame: Up to 2 weeks
PCO2 will be assessed from Day 0 to Day 15.
Up to 2 weeks
Bicarbonates
Time Frame: Up to 2 weeks
HCO3- will be assessed from Day 0 to Day 15.
Up to 2 weeks
pCO2 normalization time
Time Frame: Up to 2 weeks
Up to 2 weeks
ROX index
Time Frame: Up to 2 weeks
ROX index will be performed from Day 0 to Day 15.
Up to 2 weeks
Length of hospital stay
Time Frame: Up to 2 weeks
Duration will be recorded in days medically necessary in the pneumology department
Up to 2 weeks
Comfort Visual Analogic Scale (VAS)
Time Frame: 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.
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Cécile MAINCENT, MD, Centre Hospitalier Princesse Grace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-CHITS-012
  • 2022-A02641-42 (Other Identifier: ID-RCB number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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