Impact of Dyspnea, Regional Lung Ventilation, and Diaphragmatic Function During de Novo Acute Respiratory Failure (DY-VI-DI)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Acute Respiratory Failure

Treatments: Other: Diaphragmatic ultrasound and electrical impedance tomography

Study type: Observational

Funder types: Other

Identifiers

NCT04961437

2021-A00329-32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 1 patient group

Patients with de novo acute respiratory failure

Description:

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.

Treatment:

Other: Diaphragmatic ultrasound and electrical impedance tomography