NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases (IRAPIDPhysio)

ADIR Association

Status: Not yet enrolling

Conditions: Acute Respiratory Failure; Interstitial Lung Disease

Treatments: Device: Continuous positive airway pressure; Device: Nasal high-flow oxygen therapy; Device: Noninvasive mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT06182956

IRAPIDPhysio

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

NIV + CPAP + HFO

Experimental group

Description:

The patient will be placed under noninvasive mechanical ventilation during 30 min, then continuous positive airway pressure during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.

Treatment:

Device: Continuous positive airway pressure

Device: Nasal high-flow oxygen therapy

Device: Noninvasive mechanical ventilation

NIV + HFO + CPAP

Experimental group

Description:

The patient will be placed under noninvasive mechanical ventilation during 30 min, then nasal high-flow oxygen during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.

Treatment:

Device: Continuous positive airway pressure

Device: Nasal high-flow oxygen therapy

Device: Noninvasive mechanical ventilation

CPAP + NIV + HFO

Experimental group

Description:

The patient will be placed under continuous positive airway pressure during 30 min, then noninvasive mechanical ventilation during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.

Treatment:

Device: Continuous positive airway pressure

Device: Nasal high-flow oxygen therapy

Device: Noninvasive mechanical ventilation

CPAP + HFO + NIV

Experimental group

Description:

The patient will be placed under continuous positive airway pressure during 30 min, then nasal high-flow oxygen during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.

Treatment:

Device: Continuous positive airway pressure

Device: Nasal high-flow oxygen therapy

Device: Noninvasive mechanical ventilation

HFO + CPAP + NIV

Experimental group

Description:

The patient will be placed under nasal high-flow oxygen during 30 min, then continuous positive airway pressure during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.

Treatment:

Device: Continuous positive airway pressure

Device: Nasal high-flow oxygen therapy

Device: Noninvasive mechanical ventilation

HFO + NIV + CPAP

Experimental group

Description:

The patient will be placed under nasal high-flow oxygen during 30 min, then noninvasive mechanical ventilation during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.

Treatment:

Device: Continuous positive airway pressure

Device: Nasal high-flow oxygen therapy

Device: Noninvasive mechanical ventilation