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

Acute Respiratory Failure Clinical Trial

— DY-VI-DI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961437
• Other study ID #: 2021-A00329-32
• Status: Recruiting
• Start date: August 11, 2021
• Est. completion date: October 2024

Study information

• Verified date: December 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Martin DRES, MD PhD
• Phone: O1 42 16 78 09
• Email: martin.dres[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Dyspnea
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oro-tracheal intubation	Patients who will be intubated within the 7 days after admission in the ICU	7 days after admission in the ICU
Secondary	Diaphragmatic function	using ultrasonography, measure of diaphragmatic excursion and diaphragmatic thickening in Hertz (Hz)	2 days after inclusion
Secondary	Diaphragmatic function	Diaphragmatic function evaluation by phrenic nerve stimulation (only for intubated patients).	2 days after inclusion
Secondary	lung regional ventilation	As measured with Electric Impedance Tomography index measures (inhomogeneity index, end expiratory lung impedance change)	2 days after inclusion
Secondary	Dyspnea evaluation	Dyspnea evaluation using visual analogue scale applied to dyspnea: from 1 to 10, 1 corresponding to "no breathlessness" and 10 to "maximum breathlessness".	28 days after inclusion
Secondary	Dyspnea evaluation	Dyspnea evaluation using Respiratory Distress Observation Scale (RDOS)	28 days after inclusion
Secondary	Mechanical ventilation duration	(only for intubated patients).	28 days after inclusion
Secondary	ICU length of stay	for all patients	28 days after inclusion
Secondary	ICU mortality	for all patients	28 days after inclusion