NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases

NCT06182956 | Not Yet Recruiting

• 1 other identifier: IRAPIDPhysio
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease; Acute Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pulmonary compliance

  Comparison of global pulmonary compliance (Cglob) under noninvasive ventilation (NIV) and high-flow oxygen therapy (HFO) during acute respiratory failure in diffuse interstitial pneumonia.

  During the intervention, after an exposure of 30 minutes to the oxygen therapy device

Secondary Outcomes (181)

• Pulmonary compliance

  During the intervention, after an exposure of 30 minutes to the oxygen therapy device

• Pulmonary compliance

  During the intervention, after an exposure of 30 minutes to the oxygen therapy device

• Pulmonary compliance

  During the intervention, after an exposure of 30 minutes to the oxygen therapy device

• Pulmonary compliance

  During the intervention, after an exposure of 30 minutes to the oxygen therapy device

• Pulmonary compliance

  During the intervention, after an exposure of 30 minutes to the oxygen therapy device

Study Arms (6)

NIV + CPAP + HFO

EXPERIMENTAL

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.

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

NIV + HFO + CPAP

EXPERIMENTAL

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.

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

CPAP + NIV + HFO

EXPERIMENTAL

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.

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

CPAP + HFO + NIV

EXPERIMENTAL

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.

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

HFO + CPAP + NIV

EXPERIMENTAL

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.

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

HFO + NIV + CPAP

EXPERIMENTAL

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.

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

Interventions

Noninvasive mechanical ventilation 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.

CPAP + HFO + NIV; CPAP + NIV + HFO; HFO + CPAP + NIV; HFO + NIV + CPAP; NIV + CPAP + HFO; NIV + HFO + CPAP

Nasal high-flow oxygen therapy DEVICE

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

CPAP + HFO + NIV; CPAP + NIV + HFO; HFO + CPAP + NIV; HFO + NIV + CPAP; NIV + CPAP + HFO; NIV + HFO + CPAP

Continuous positive airway pressure 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; CPAP + NIV + HFO; HFO + CPAP + NIV; HFO + NIV + CPAP; NIV + CPAP + HFO; NIV + HFO + CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR Association

Rouen, 76000, France

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Elise ARTAUD-MACARI, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise ARTAUD-MACARI, MD

CONTACT

+33232885992; elise.artaud-macari@chu-rouen.fr

Maryline LEFORT

CONTACT

+33232885992; mlefort@adir-hautenormandie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: December 27, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

FR (1)