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

Recruiting

• Conditions: Acute Respiratory Failure

• Registration Number: NCT04961437
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-14
• Study Start: 2021-08-11
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-02
• Primary Completion: 2025-09-11
• Study Completion: 2025-09-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mechanical ventilation duration	28 days after inclusion	(only for intubated patients).
ICU length of stay	28 days after inclusion	for all patients
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 Respiratory Distress Observation Scale (RDOS)
ICU mortality	28 days after inclusion	for all patients

Trial Locations

Locations (1)

Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit; 🇫🇷 Paris, France