Clinical trial NCT06182956: NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases
Official title: Evaluation of Physiological Effects of Noninvasive Mechanical Ventilation and High-flow Oxygen Therapy for Acute Exacerbations of Interstitial Lung Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Acute Respiratory Failure
Keywords: Noninvasive mechanical ventilation
Nasal high-flow oxygen therapy
Respiratory work
Hemodynamics
Diaphragm
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Pulmonary compliance
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Secondary outcomes:
measure: Pulmonary compliance
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulmonary compliance
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulmonary compliance
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulmonary compliance
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulmonary compliance
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Tidal volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Tidal volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Tidal volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Tidal volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Tidal volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Tidal volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: end-expiratory lung volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: end-expiratory lung volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: end-expiratory lung volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: end-expiratory lung volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: end-expiratory lung volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: end-expiratory lung volume
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transpulmonary pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transpulmonary pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transpulmonary pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transpulmonary pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transpulmonary pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transpulmonary pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: driving pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: driving pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: driving pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: driving pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: driving pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: driving pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Global inhomogeneity index
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Global inhomogeneity index
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Global inhomogeneity index
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Global inhomogeneity index
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Global inhomogeneity index
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Global inhomogeneity index
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: respiratory rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: respiratory rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: respiratory rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: respiratory rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: respiratory rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: respiratory rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: inspiratory time
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: inspiratory time
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: inspiratory time
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: inspiratory time
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: inspiratory time
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: inspiratory time
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: inspiratory time
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure swings
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure swings
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure swings
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure swings
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure swings
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure swings
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure variations
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure variations
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure variations
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure variations
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure variations
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure variations
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transdiaphragmatic pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: oesophagal pressure time products
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: ultrasound diaphragmatic strain.
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: diaphragmatic thickening fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: diaphragmatic thickening fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: diaphragmatic thickening fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: diaphragmatic thickening fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: diaphragmatic thickening fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: diaphragmatic thickening fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak inspiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak inspiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak inspiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak inspiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak inspiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak inspiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak expiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak expiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak expiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak expiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak expiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: peak expiratory flow
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Systolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Systolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Systolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Systolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Systolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Systolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Diastolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Diastolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Diastolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Diastolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Diastolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Diastolic arterial pressures
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Mean arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Mean arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Mean arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Mean arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Mean arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Mean arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: systolic pulmonary arterial pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: tricuspid annular plane systolic excursion
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: tricuspid annular plane systolic excursion
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: tricuspid annular plane systolic excursion
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: tricuspid annular plane systolic excursion
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: tricuspid annular plane systolic excursion
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: tricuspid annular plane systolic excursion
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right ventricular strain
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right ventricular strain
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right ventricular strain
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right ventricular strain
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right ventricular strain
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right ventricular strain
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: left ventricular ejection fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: left ventricular ejection fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: left ventricular ejection fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: left ventricular ejection fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: left ventricular ejection fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: left ventricular ejection fraction
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: E/E' ratio
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: E/E' ratio
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: E/E' ratio
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: E/E' ratio
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: E/E' ratio
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: E/E' ratio
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right auricular pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right auricular pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right auricular pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right auricular pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right auricular pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: right auricular pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: cardiac output
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: cardiac output
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: cardiac output
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: cardiac output
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: cardiac output
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: cardiac output
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: heart rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: heart rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: heart rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: heart rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: heart rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: heart rate
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulsed oxymetry
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulsed oxymetry
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulsed oxymetry
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulsed oxymetry
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulsed oxymetry
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Pulsed oxymetry
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transcutaneous carbon dioxide pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transcutaneous carbon dioxide pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transcutaneous carbon dioxide pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transcutaneous carbon dioxide pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transcutaneous carbon dioxide pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: transcutaneous carbon dioxide pressure
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Dyspnea
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Dyspnea
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Dyspnea
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Dyspnea
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Dyspnea
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Dyspnea
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Comparison of Comfort
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Comparison of Comfort
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Comparison of Comfort
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Comparison of Comfort
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Comparison of Comfort
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
measure: Comparison of Comfort
timeFrame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Other outcomes:
Locations:
city: Rouen
country: France
facility: ADIR Association
Study officials:
affiliation: University Hospital, Rouen
name: Elise ARTAUD-MACARI, MD
role: PRINCIPAL_INVESTIGATOR
References: