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NCT Number: NCT04961437

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

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.

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Key information

Conditions

Acute Respiratory Failure Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit

Paris, 75013, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18
  • Acute respiratory insufficiency defined by the three following items :
  • PaO2/ FiO2 <300
  • Respiratory rate > 25/min
  • 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.

Treatment and study plan

Diaphragmatic ultrasound and electrical impedance tomography

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.

Primary outcomes

  1. Oro-tracheal intubation

    Time frame: 7 days after admission in the ICU

    Patients who will be intubated within the 7 days after admission in the ICU

Secondary outcomes

  1. Diaphragmatic function

    Time frame: 2 days after inclusion

    using ultrasonography, measure of diaphragmatic excursion and diaphragmatic thickening in Hertz (Hz)

  2. Diaphragmatic function

    Time frame: 2 days after inclusion

    Diaphragmatic function evaluation by phrenic nerve stimulation (only for intubated patients).

  3. lung regional ventilation

    Time frame: 2 days after inclusion

    As measured with Electric Impedance Tomography index measures (inhomogeneity index, end expiratory lung impedance change)

  4. Dyspnea evaluation

    Time frame: 28 days after inclusion

    Dyspnea evaluation using visual analogue scale applied to dyspnea: from 1 to 10, 1 corresponding to "no breathlessness" and 10 to "maximum breathlessness".

  5. Dyspnea evaluation

    Time frame: 28 days after inclusion

    Dyspnea evaluation using Respiratory Distress Observation Scale (RDOS)

  6. Mechanical ventilation duration

    Time frame: 28 days after inclusion

    (only for intubated patients).

  7. ICU length of stay

    Time frame: 28 days after inclusion

    for all patients

  8. ICU mortality

    Time frame: 28 days after inclusion

    for all patients

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evaluation of Dyspnea, Pulmonary VentIlation and DIaphragmatic Function in de Novo Adult Acute Respiratory Failure.

Acronym: DY-VI-DI

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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