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

NCT04961437 | Completed

• 1 other identifier: 2021-A00329-32
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

Acute respiratory failure; diaphragm; dyspnea; EIT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Diaphragmatic function

  2 days after inclusion

• Diaphragmatic function

  2 days after inclusion

• lung regional ventilation

  2 days after inclusion

• Dyspnea evaluation

  28 days after inclusion

• Dyspnea evaluation

  28 days after inclusion

Study Arms (1)

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

Interventions

Diaphragmatic ultrasound and electrical impedance tomography OTHER

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.

Patients with de novo acute respiratory failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with de novo acute respiratory failure

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit

Paris, 75013, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin DRES, MD PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 14, 2021
• Study Start: August 11, 2021
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)