NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases
Launched by ADIR ASSOCIATION · Dec 13, 2023
Trial Information
Current as of August 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to compare two types of treatments for patients experiencing severe breathing problems due to acute exacerbations of interstitial lung disease, a condition that affects the lung tissue. Specifically, the study will look at how high-flow oxygen therapy and noninvasive mechanical ventilation (a method that helps patients breathe without needing a breathing tube) affect breathing, effort required to breathe, and blood circulation during these critical moments.
To qualify for this trial, participants must be over 18 years old, currently hospitalized in an intensive care unit, and have experienced worsening shortness of breath for at least a month. They should also have specific lung changes visible on a CT scan and need extra oxygen support. However, certain individuals, such as those with serious heart problems, obesity, or certain medical devices, will not be eligible to participate. If enrolled, participants can expect to receive either of the two treatments while the research team closely monitors their breathing and overall health. This study aims to find out which treatment might work better for patients in this challenging situation.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • Age \> 18 yrs
- • Hospitalization in intensive care unit
- • Acute exacerbation of a previously/presently documented diffuse (fibrotic) interstitial lung disease
- • Dyspnea majoration since at least 1 month
- • Alveolar or ground-glass opacities on CT-scan that are superposed to interstitial lung disease and not explained by left heart failure or volume overload
- • Hypoxemia requiring oxygen flows \> 6 L/min
- Exclusion criteria:
- • Contraindication to noninvasive ventilation or high-flow oxygen therapy
- • Immediate indication to endotracheal intubation or hemodynamic assistance
- • Body mass index \> 40
- • Presence of a pacemaker or an implantable defibrillator
- • Presence of cutaneous lesions where Pulmovista® belt should be placed
- • Moribund patient
- • Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception
- • Protected adult patient (tutorship or curatorship)
- • Patient deprived of liberty by court or administrative decision
- • No possibility to install nasogastric tube
- • Endotracheal or tracheostomy tube requirement during the study
- • Hemodynamic assistance requirement during the study
About Adir Association
The Adir Association is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapies. With a focus on collaboration and integrity, the organization designs and oversees clinical studies across a range of therapeutic areas, ensuring adherence to regulatory standards and ethical practices. By fostering partnerships with healthcare professionals, academic institutions, and industry stakeholders, the Adir Association aims to accelerate the development of safe and effective treatments that address unmet medical needs, ultimately enhancing the quality of care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rouen, , France
Patients applied
Trial Officials
Elise ARTAUD-MACARI, MD
Principal Investigator
University Hospital, Rouen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported