DyspneaPREDIRENCT04119505
Value of Diaphragmatic Motion Measurement at Ultrasonography to Predict Poor Prognosis in Emergency Department Patients With Acute Respiratory Failure
An observational study of Dyspnea and Acute Respiratory Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Acute respiratory failure is one of the most common diagnosis in patients admitted in the Emergency Department. Acute respiratory failure is associated with morbidity and mortality. Fifteen percent of patient will require ventilatory support and among them 40% will die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Acute Respiratory Failure
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 28 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted in the Emergency Department for Acute Respiratory Failure
Who may be able to join
- Age equal or over 18 y.o
- Signs of acute respiratory failure defined by RR equal or over 25 br/min and/or signs of increased work of breathing
- Patients on spontaneous breathing
Who cannot join
- Medical history of diaphragmatic dysfunction including stroke or diaphragmatic paralysis
- Patients on ventilatory support at ED admission or prior to inclusion
- Patients treated with curare
- Trauma patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pronostic Value of Diaphragmatic Excursion Measurement in Patients With Acute Respiratory Failure in the ED.
Acute respiratory failure is one of the most common diagnosis in patients admitted in the Emergency Department. Acute respiratory failure is associated with morbidity and mortality. Fifteen percent of patient will require ventilatory support and among them 40% will die.
Measurement of diaphragmatic motion (excursion) at ultrasonography is a noninvasive measure, allowing to assess diaphragm dysfunction. It could be useful in predicting poor prognosis in ED patients with respiratory failure .
Read more
In this study the investigators will compare the prognostic value of diaphragmatic excursion measurement at ultrasonography to that of the National Early Warning Score (NEWS) 2 in patients presenting with acute respiratory failure in the ED
The Investigators made the hypothesis that measurement of diaphragmatic excursion in ED patients with acute respiratory failure could be of value in predicting the need for ventilatory support or mortality within 28 days from ED admission
Read the detailed description
Diaphragmatic dysfunction can be explored by measuring diaphragmatic excursion using ultrasonography in spontaneous ventilation patients.
Patients in spontaneous ventilation will undergo both diaphragmatic excursion measurement at ultrasonography and assessment of the News2 score as part of standard care.
- Conditions
- Dyspnea, Acute Respiratory Failure
- Keywords
- Diaphragmatic Excursion, Diaphragmatic Dysfunction, Emergency Department, Respiratory insufficiency, Acute respiratory failure
- Medical subject headings
- Dyspnea, Emergencies, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy) within 28 days from ED admission.
Measured: 28 days
Secondary outcomes (3)
Delay to initiation of ventilatory support
Ventilatory support is defined as invasive mechanical ventilation or non invasive ventilation or high-flow nasal cannula
Measured: at day 28
Number of patients with adverse events at ED discharge
Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy).
Measured: through ED stay (up to a day)
Number of patients with adverse events at hospital discharge
Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy).
Measured: through hospital stay (up to a week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Nov 2019
- Primary completion1 Nov 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Poitiers University Hospital, University Hospital, Brest, Nord-Vienne Hospital
- Responsible party
- Sponsor
- Investigators
- Nicolas MARJANOVIC, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119505
- Sponsor's protocol ID
- RECHMPL19_0141
- Acronym
- PREDIRE
- Status last verified
- Dec 2020
- First submitted
- 25 Sep 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pronostic Value of Diaphragmatic Excursion Measurement in Patients With Acute Respiratory Failure in the ED.
- ClinicalTrials.gov ID
- NCT04119505
- Acronym / sponsor ID
- PREDIRE / RECHMPL19_0141
- Conditions
- Dyspnea, Acute Respiratory Failure
- Keywords
- Diaphragmatic Excursion, Diaphragmatic Dysfunction, Emergency Department, Respiratory insufficiency, Acute respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Poitiers University Hospital, University Hospital, Brest, Nord-Vienne Hospital
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 8 Oct 2019 (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.
Acute respiratory failure is one of the most common diagnosis in patients admitted in the Emergency Department. Acute respiratory failure is associated with morbidity and mortality. Fifteen percent of patient will require ventilatory support and among them 40% will die.
Measurement of diaphragmatic motion (excursion) at ultrasonography is a noninvasive measure, allowing to assess diaphragm dysfunction. It could be useful in predicting poor prognosis in ED patients with respiratory failure .
In this study the investigators will compare the prognostic value of diaphragmatic excursion measurement at ultrasonography to that of the National Early Warning Score (NEWS) 2 in patients presenting with acute respiratory failure in the ED
The Investigators made the hypothesis that measurement of diaphragmatic excursion in ED patients with acute respiratory failure could be of value in predicting the need for ventilatory support or mortality within 28 days from ED admission
Detailed description
Diaphragmatic dysfunction can be explored by measuring diaphragmatic excursion using ultrasonography in spontaneous ventilation patients.
Patients in spontaneous ventilation will undergo both diaphragmatic excursion measurement at ultrasonography and assessment of the News2 score as part of standard care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted in the Emergency Department for Acute Respiratory Failure
Key inclusion criteria (3 listed)
- Age equal or over 18 y.o
- Signs of acute respiratory failure defined by RR equal or over 25 br/min and/or signs of increased work of breathing
- Patients on spontaneous breathing
Key exclusion criteria (4 listed)
- Medical history of diaphragmatic dysfunction including stroke or diaphragmatic paralysis
- Patients on ventilatory support at ED admission or prior to inclusion
- Patients treated with curare
- Trauma patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with adverse events
Time frame: 28 days
Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy) within 28 days from ED admission.
3 secondary outcomes
Delay to initiation of ventilatory support
Time frame: at day 28
Number of patients with adverse events at ED discharge
Time frame: through ED stay (up to a day)
Number of patients with adverse events at hospital discharge
Time frame: through hospital stay (up to a week)
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 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Nicolas MARJANOVIC, MD principal investigator
University Hospital, Montpellier
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 Dyspnea and Acute Respiratory Failure, run by University Hospital, Montpellier 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 3 inclusion and 4 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 29 Dec 2020. 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?
Number of patients with adverse events (time frame: 28 days). 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 29 Dec 2020.