Clinical Trials Directory

Trials / Terminated

TerminatedNCT06008587

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICEAIRVO3 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.
OTHERStandard 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.

Timeline

Start date
2024-02-27
Primary completion
2025-09-24
Completion
2025-09-24
First posted
2023-08-23
Last updated
2025-11-24

Locations

3 sites across 2 countries: France, Monaco

Source: ClinicalTrials.gov record NCT06008587. Inclusion in this directory is not an endorsement.