Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04961437
Acronym
DY-VI-DI
Enrollment
55
Registered
2021-07-14
Start date
2021-08-11
Completion date
2025-07-22
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Acute respiratory failure, diaphragm, dyspnea, EIT

Brief summary

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

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.

Interventions

OTHERDiaphragmatic 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Oro-tracheal intubation7 days after admission in the ICUPatients who will be intubated within the 7 days after admission in the ICU

Secondary

MeasureTime frameDescription
Diaphragmatic function2 days after inclusionusing ultrasonography, measure of diaphragmatic excursion and diaphragmatic thickening in Hertz (Hz)
lung regional ventilation2 days after inclusionAs measured with Electric Impedance Tomography index measures (inhomogeneity index, end expiratory lung impedance change)
Dyspnea evaluation28 days after inclusionDyspnea evaluation using visual analogue scale applied to dyspnea: from 1 to 10, 1 corresponding to "no breathlessness" and 10 to "maximum breathlessness".
Mechanical ventilation duration28 days after inclusion(only for intubated patients).
ICU length of stay28 days after inclusionfor all patients
ICU mortality28 days after inclusionfor all patients

Countries

France

Contacts

STUDY_DIRECTORMartin DRES, MD PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026