search
Back to results

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

Primary Purpose

Respiratory Insufficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AIRVO3 TM
Standard therapy
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Nasal High Flow, Acute Respiratory Failure, Respiratory non-acidosis, Pneumology, Hypercapnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Major patient ≥ 18 years old Medical diagnosis of Acute Respiratory Failure less than 24 hours With partial pressure of carbon dioxide (PaCO2) ≥ 45 and pH > 7.35 for less than 24hours, 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 Exclusion Criteria: Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies Drug-induced Acute respiratory failure Pneumothorax (X-ray pulmonary detachment) Oxygen poisoning (Peripheral oxygen saturation (SpO2) ≥95%) 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

Sites / Locations

  • Centre Hospitalier de Cannes
  • Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
  • Centre Hospitalier Princesse Grace

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nasal High Flow therapy in association with the standard therapy

Standard therapy alone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Etiology of acute respiratory failure
The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ...
Respiratory rate
Respiratory rate will be recorded from Day 0 to Day 15, or until discharge (if less than 15 days).
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.
pH
pH will be assessed from Day 0 to Day 15.
Partial Pressure of Carbon dioxide (PCO2)
PCO2 will be assessed from Day 0 to Day 15.
Bicarbonates
HCO3- will be assessed from Day 0 to Day 15.
pCO2 normalization time
ROX index
ROX index will be performed from Day 0 to Day 15.
Length of hospital stay
Duration will be recorded in days medically necessary in the pneumology department
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.

Full Information

First Posted
August 11, 2023
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
search

1. Study Identification

Unique Protocol Identification Number
NCT06008587
Brief Title
Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
Acronym
PIRAHNA
Official Title
Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 : 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Nasal High Flow, Acute Respiratory Failure, Respiratory non-acidosis, Pneumology, Hypercapnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal High Flow therapy in association with the standard therapy
Arm Type
Experimental
Arm Title
Standard therapy alone
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
AIRVO3 TM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Failure of the Nasal High Flow
Description
Failure of the Nasal High Flow is defined by the occurrence of respiratory acidosis (pH<7.35) within 2 weeks after admission
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Responding patients phenotype
Description
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.
Time Frame
At Day 30 after hospital discharge
Title
Etiology of acute respiratory failure
Description
The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ...
Time Frame
Up to 2 weeks
Title
Respiratory rate
Description
Respiratory rate will be recorded from Day 0 to Day 15, or until discharge (if less than 15 days).
Time Frame
Up to 2 weeks
Title
Dyspnea
Description
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.
Time Frame
Up to 2 weeks
Title
pH
Description
pH will be assessed from Day 0 to Day 15.
Time Frame
Up to 2 weeks
Title
Partial Pressure of Carbon dioxide (PCO2)
Description
PCO2 will be assessed from Day 0 to Day 15.
Time Frame
Up to 2 weeks
Title
Bicarbonates
Description
HCO3- will be assessed from Day 0 to Day 15.
Time Frame
Up to 2 weeks
Title
pCO2 normalization time
Time Frame
Up to 2 weeks
Title
ROX index
Description
ROX index will be performed from Day 0 to Day 15.
Time Frame
Up to 2 weeks
Title
Length of hospital stay
Description
Duration will be recorded in days medically necessary in the pneumology department
Time Frame
Up to 2 weeks
Title
Comfort Visual Analogic Scale (VAS)
Description
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.
Time Frame
Up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major patient ≥ 18 years old Medical diagnosis of Acute Respiratory Failure less than 24 hours With partial pressure of carbon dioxide (PaCO2) ≥ 45 and pH > 7.35 for less than 24hours, 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 Exclusion Criteria: Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies Drug-induced Acute respiratory failure Pneumothorax (X-ray pulmonary detachment) Oxygen poisoning (Peripheral oxygen saturation (SpO2) ≥95%) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magali CESANA
Phone
0494145525
Ext
+33
Email
magali.cesana@ch-toulon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile MAINCENT, MD
Organizational Affiliation
Centre Hospitalier Princesse Grace
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier de Cannes
City
Cannes
State/Province
Alpes Maritime
ZIP/Postal Code
06400
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien ROLLAND, MD
Phone
0493697860
Ext
+33
Email
f.rolland@ch-cannes.fr
Facility Name
Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
City
Toulon
State/Province
Var
ZIP/Postal Code
83100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien MERRIEN, MD
Phone
0494145000
Ext
+33
Email
julien.merrien@ch-toulon.fr
Facility Name
Centre Hospitalier Princesse Grace
City
Monaco
ZIP/Postal Code
98000
Country
Monaco
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile MAINCENT, MD
Phone
097989741
Ext
+377
Email
cecile.maincent@chpg.mc

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs