NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases

NCT ID: NCT06182956

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Interstitial Lung Disease Acute Respiratory Failure

Keywords

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Noninvasive mechanical ventilation Nasal high-flow oxygen therapy Respiratory work Hemodynamics Diaphragm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NIV + CPAP + HFO

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.

Group Type EXPERIMENTAL

Noninvasive mechanical ventilation

Intervention Type DEVICE

Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.

Nasal high-flow oxygen therapy

Intervention Type DEVICE

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.

Continuous positive airway pressure

Intervention Type DEVICE

Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

NIV + HFO + CPAP

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.

Group Type EXPERIMENTAL

Noninvasive mechanical ventilation

Intervention Type DEVICE

Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.

Nasal high-flow oxygen therapy

Intervention Type DEVICE

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.

Continuous positive airway pressure

Intervention Type DEVICE

Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

CPAP + NIV + HFO

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.

Group Type EXPERIMENTAL

Noninvasive mechanical ventilation

Intervention Type DEVICE

Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.

Nasal high-flow oxygen therapy

Intervention Type DEVICE

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.

Continuous positive airway pressure

Intervention Type DEVICE

Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

CPAP + HFO + NIV

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.

Group Type EXPERIMENTAL

Noninvasive mechanical ventilation

Intervention Type DEVICE

Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.

Nasal high-flow oxygen therapy

Intervention Type DEVICE

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.

Continuous positive airway pressure

Intervention Type DEVICE

Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

HFO + CPAP + NIV

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.

Group Type EXPERIMENTAL

Noninvasive mechanical ventilation

Intervention Type DEVICE

Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.

Nasal high-flow oxygen therapy

Intervention Type DEVICE

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.

Continuous positive airway pressure

Intervention Type DEVICE

Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

HFO + NIV + CPAP

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.

Group Type EXPERIMENTAL

Noninvasive mechanical ventilation

Intervention Type DEVICE

Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.

Nasal high-flow oxygen therapy

Intervention Type DEVICE

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.

Continuous positive airway pressure

Intervention Type DEVICE

Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADIR Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise ARTAUD-MACARI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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ADIR Association

Rouen, , France

Site Status

Countries

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France

Central Contacts

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Elise ARTAUD-MACARI, MD

Role: CONTACT

Phone: +33232885992

Email: [email protected]

Maryline LEFORT

Role: CONTACT

Phone: +33232885992

Email: [email protected]

Facility Contacts

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Elise ARTAUD-MACARI, MD

Role: primary

Other Identifiers

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IRAPIDPhysio

Identifier Type: -

Identifier Source: org_study_id