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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04961437

Collaborator

(none)

120

Enrollment

Location

20.6

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure	Other: Diaphragmatic ultrasound and electrical impedance tomography

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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.

Arm

Intervention/Treatment

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Oro-tracheal intubation [7 days after admission in the ICU]
Patients who will be intubated within the 7 days after admission in the ICU

Secondary Outcome Measures

Diaphragmatic function [2 days after inclusion]
using ultrasonography, measure of diaphragmatic excursion and diaphragmatic thickening in Hertz (Hz)
Diaphragmatic function [2 days after inclusion]
Diaphragmatic function evaluation by phrenic nerve stimulation (only for intubated patients).
lung regional ventilation [2 days after inclusion]
As measured with Electric Impedance Tomography index measures (inhomogeneity index, end expiratory lung impedance change)
Dyspnea evaluation [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".
Dyspnea evaluation [28 days after inclusion]
Dyspnea evaluation using Respiratory Distress Observation Scale (RDOS)
Mechanical ventilation duration [28 days after inclusion]
(only for intubated patients).
ICU length of stay [28 days after inclusion]
for all patients
ICU mortality [28 days after inclusion]
for all patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.