Impact of Dyspnea, Regional Lung Ventilation, and Diaphragmatic Function During de Novo Acute Respiratory Failure

NCT ID: NCT04961437

Last Updated: 2025-07-02

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

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-11

Study Completion Date

2025-09-11

Brief Summary

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Modern management of acute respiratory failure aims to relieve dyspnea and anxiety by providing a non-invasive respiratory support. This approach tries to avoid endotracheal intubation, patient self inflicted lung injuries (PSILI) and diaphragmatic dysfunction. The present study aims to evaluate dyspnea, pulmonary regional ventilation and diaphragmatic function in patients with hypoxemic acute respiratory failure by different observations, and to bring risk factor for intubation out.

Detailed Description

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Patients aged of 18 years or more, presenting with an acute respiratory failure without hypercapnia will be included in the study. Clinical and biological variables, dyspnea assessment, regional lung ventilation (electrical impedance tomography) and diaphragm function (ultrasound) will be evaluated at inclusion and at 2 hours, 4 hours and 48 hours after inclusion. In case of intubation, diaphragmatic function will be also evaluated with phrenic nerve stimulation technique.

Primary endpoint is intubation at day 7. Secondary endpoints are measurement of dyspnea, pulmonary ventilation and diaphragmatic function, also ventilator free days, ICU length of stay and mortality.

Conditions

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Acute Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with de novo acute respiratory failure

The following tests will be performed as part of the research (these tests are usually performed as part of routine care but not routinely and comprehensively):

* A diaphragmatic ultrasound in the half-seated position. Diaphragmatic excursion and thickening fraction will be measured in the right hemi-diaphragm.
* A 10-minute reference acquisition. They will be performed at inclusion, H2, H4 and H48.

Diaphragmatic ultrasound and electrical impedance tomography

Intervention Type OTHER

A diaphragmatic ultrasound in a half sitting position. The diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm will be measured.

\- Acquisition of 10 minutes of regional pulmonary ventilation by electrical impedance tomography.

Interventions

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Diaphragmatic ultrasound and electrical impedance tomography

A diaphragmatic ultrasound in a half sitting position. The diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm will be measured.

\- Acquisition of 10 minutes of regional pulmonary ventilation by electrical impedance tomography.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Acute respiratory insufficiency defined by the three following items :

1. PaO2/ FiO2 \<300
2. Respiratory rate \> 25/min
3. Oxygen support \> 10L/min or High Flow nasal oxygen (HFNO)
* Non opposition by the patient to be included
* Social insurance

Exclusion Criteria

* Respiratory acidosis (pH \< 7,35 PaCO2 \> 45mmHg or 6kPa)
* Chronic respiratory disease ( COPD, bronchiectasis…)
* Cardiogenic Acute lung oedema
* Non intubation decision at randomisation
* Contraindication for Electro-impedance tomography-belt placement (chest trauma with rib fractures, thoracic wound, chest tube).
* Uncommunicative patient (Glasgow coma scale \<12)
* Guardianship or curators for vulnerable patients.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin DRES, MD PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Martin DRES, MD PhD

Role: CONTACT

O1 42 16 78 09

Sébastien Clerc, MD

Role: CONTACT

06 47 21 69 77

Facility Contacts

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Martin Dres, MD phD

Role: primary

01 42 16 78 09

Other Identifiers

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2021-A00329-32

Identifier Type: -

Identifier Source: org_study_id

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