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Not yet recruiting NCT06182956

NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases

No phase Interventional Interstitial Lung Disease Acute Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Noninvasive mechanical ventilation, Nasal high-flow oxygen therapy, Continuous positive airway pressure.
Who it may be relevant to
Registry conditions: Interstitial Lung Disease, Acute Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of Physiological Effects of Noninvasive Mechanical Ventilation and High-flow Oxygen Therapy for Acute Exacerbations of Interstitial Lung Diseases

Overview

The objectives of this study are to compare the physiological consequences of high-flow oxygen therapy and noninvasive mechanical ventilation on ventilation, respiratory work and hemodynamics during acute respiratory failure in diffuse interstitial pneumonia.

Interventions

  • Device Noninvasive mechanical ventilation
    Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.
  • Device Nasal high-flow oxygen therapy
    Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.
  • Device Continuous positive airway pressure
    Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

Primary outcome measures

  • Pulmonary compliance [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
Secondary outcome measures (12)
  • Pulmonary compliance [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Pulmonary compliance [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Pulmonary compliance [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Pulmonary compliance [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Pulmonary compliance [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Tidal volume [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Tidal volume [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Tidal volume [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Tidal volume [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Tidal volume [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • Tidal volume [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]
  • end-expiratory lung volume [Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • ADIR Association — Rouen

Identifiers

NCT: NCT06182956 · IRAPIDPhysio

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗