Impact of Dyspnea, Regional Lung Ventilation, and Diaphragmatic Function During de Novo Acute Respiratory Failure
NCT ID: NCT04961437
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
120 participants
OBSERVATIONAL
2021-08-11
2025-09-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sonographic Evaluation of Diaphragmatic Function Under Nasal High-flow (NHF) and Non-invasive Ventilation (NIV) in Respiratory Insufficiency
NCT07050147
NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases
NCT06182956
Multicenter Prospective Observational Study on Diaphragmatic Function Assessment by Ultrasound in Patients with Acute Respiratory Failure Receiving Non-invasive Mechanical Ventilation or High Flow Nasal Canula
NCT06892912
Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation
NCT02380547
Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
NCT04962568
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin DRES, MD PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-A00329-32
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.