Acute Respiratory FailureDY-VI-DINCT04961437
Impact of Dyspnea, Regional Lung Ventilation, and Diaphragmatic Function During de Novo Acute Respiratory Failure
An observational study of Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Diaphragmatic ultrasound and electrical impedance tomography
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2021to 22 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with de novo acute respiratory failure
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit
Paris, 75013
About this study
Official title: Evaluation of Dyspnea, Pulmonary VentIlation and DIaphragmatic Function in de Novo Adult Acute Respiratory Failure.
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.
Read the 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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Diaphragmatic ultrasound and electrical impedance tomography
- Keywords
- Acute respiratory failure, diaphragm, dyspnea, EIT
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic ultrasound and electrical impedance tomographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diaphragmatic ultrasound and electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oro-tracheal intubation
Patients who will be intubated within the 7 days after admission in the ICU
Measured: 7 days after admission in the ICU
Secondary outcomes (8)
Diaphragmatic function
using ultrasonography, measure of diaphragmatic excursion and diaphragmatic thickening in Hertz (Hz)
Measured: 2 days after inclusion
Diaphragmatic function
Diaphragmatic function evaluation by phrenic nerve stimulation (only for intubated patients).
Measured: 2 days after inclusion
lung regional ventilation
As measured with Electric Impedance Tomography index measures (inhomogeneity index, end expiratory lung impedance change)
Measured: 2 days after inclusion
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".
Measured: 28 days after inclusion
Dyspnea evaluation
Dyspnea evaluation using Respiratory Distress Observation Scale (RDOS)
Measured: 28 days after inclusion
Mechanical ventilation duration
(only for intubated patients).
Measured: 28 days after inclusion
ICU length of stay
for all patients
Measured: 28 days after inclusion
ICU mortality
for all patients
Measured: 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start11 Aug 2021
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin DRES, MD PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961437
- Sponsor's protocol ID
- 2021-A00329-32
- Acronym
- DY-VI-DI
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dyspnea, Pulmonary VentIlation and DIaphragmatic Function in de Novo Adult Acute Respiratory Failure.
- ClinicalTrials.gov ID
- NCT04961437
- Acronym / sponsor ID
- DY-VI-DI / 2021-A00329-32
- Conditions
- Acute Respiratory Failure
- Keywords
- Acute respiratory failure, diaphragm, dyspnea, EIT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with de novo acute respiratory failure | – | Other: Diaphragmatic ultrasound and electrical impedance tomographyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with de novo acute respiratory failure
Key inclusion criteria (7 listed)
- Age > 18
- Acute respiratory insufficiency defined by the three following items :
- Non opposition by the patient to be included
- Social insurance
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic ultrasound and electrical impedance tomographyA 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. | Other | Patients with de novo acute respiratory failure |
Primary outcome
Oro-tracheal intubation
Time frame: 7 days after admission in the ICU
Patients who will be intubated within the 7 days after admission in the ICU
8 secondary outcomes
Diaphragmatic function
Time frame: 2 days after inclusion
Diaphragmatic function
Time frame: 2 days after inclusion
lung regional ventilation
Time frame: 2 days after inclusion
Dyspnea evaluation
Time frame: 28 days after inclusion
Dyspnea evaluation
Time frame: 28 days after inclusion
Mechanical ventilation duration
Time frame: 28 days after inclusion
ICU length of stay
Time frame: 28 days after inclusion
ICU mortality
Time frame: 28 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin DRES, MD PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oro-tracheal intubation (time frame: 7 days after admission in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.