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

NCT06008587 | Terminated

• 2 other identifiers: 2022-CHITS-0122022-A02641-42
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 3

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.

Conditions

Respiratory Insufficiency

Keywords

Nasal High Flow; Acute Respiratory Failure; Respiratory non-acidosis; Pneumology; Hypercapnia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Responding patients phenotype

  At Day 30 after hospital discharge

• Etiology of acute respiratory failure

  Up to 2 weeks

• Respiratory rate

  Up to 2 weeks

• Dyspnea

  Up to 2 weeks

• pH

  Up to 2 weeks

Study Arms (2)

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

Interventions

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.

Nasal High Flow therapy in association with the standard therapy

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.

Nasal High Flow therapy in association with the standard therapy; Standard therapy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (3)

Centre Hospitalier de Cannes

Cannes, Alpes Maritime, 06400, France

Location

Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse

Toulon, Var, 83100, France

Location

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Hypercapnia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Cécile MAINCENT, MD

  Centre Hospitalier Princesse Grace

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 23, 2023
• Study Start: February 27, 2024
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (2); MO (1)