Critical CareECHODIANCT02380547
Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation
An observational study of Critical Care and Invasive Mechanical Ventilation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Usefulness of non invasive ventilation in patients extubated after more than 48 hours of invasive ventilation is still in debate except for specific patients (chronic pulmonary disease and chronic heart failure). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Invasive Mechanical Ventilation
- What is being tested?
- Sonographic diaphragmatic measurements
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2015to 15 Jul 2016
- 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: Critical care patients (surgical or medical)
Who may be able to join
- Patient extubated after at least 48 hours of invasive ventilation
- Requiring non invasive ventilation
- Consent of patient
Who cannot join
- Diaphragmatic paralysis
- Neuromuscular disease
- significant pleural effusion
- atelectasis requiring bronchoscopy
- abdominal hypertension
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'anesthésie- réanimation chirurgicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Usefulness of non invasive ventilation in patients extubated after more than 48 hours of invasive ventilation is still in debate except for specific patients (chronic pulmonary disease and chronic heart failure).
Many experimental and clinical studies have shown that diaphragmatic function is depressed by mechanical ventilation in intubated patients.
The investigators will test the hypothesis that non invasive ventilation after extubation may improve diaphragmatic function
- Conditions
- Critical Care, Invasive Mechanical Ventilation
- Being tested
- Sonographic diaphragmatic measurements
- Keywords
- Sonography, Diaphragmatic function, Non invasive ventilation, Critical care patients, Extubation after 24 hours of invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic diaphragmatic measurementsOther
Also called Diaphragmatic excursion, Diaphragmatic thickening
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic excursion
Measured: Before the first NIV session
Diaphragmatic thickening
Measured: Before the first NIV session
Diaphragmatic excursion
Measured: After the first NIV session
Diaphragmatic thickening
Measured: After the first NIV session
Diaphragmatic excursion
Measured: After 24 h of NIV use
Diaphragmatic thickening
Measured: After 24 h of NIV use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study start19 Jun 2015
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gharib AJOB, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380547
- Sponsor's protocol ID
- 5957
- Acronym
- ECHODIA
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation
- ClinicalTrials.gov ID
- NCT02380547
- Acronym / sponsor ID
- ECHODIA / 5957
- Conditions
- Critical Care, Invasive Mechanical Ventilation
- Keywords
- Sonography, Diaphragmatic function, Non invasive ventilation, Critical care patients, Extubation after 24 hours of invasive ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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.
Usefulness of non invasive ventilation in patients extubated after more than 48 hours of invasive ventilation is still in debate except for specific patients (chronic pulmonary disease and chronic heart failure).
Many experimental and clinical studies have shown that diaphragmatic function is depressed by mechanical ventilation in intubated patients.
The investigators will test the hypothesis that non invasive ventilation after extubation may improve diaphragmatic function
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
- Critical care patients (surgical or medical)
Key inclusion criteria (3 listed)
- Patient extubated after at least 48 hours of invasive ventilation
- Requiring non invasive ventilation
- Consent of patient
Key exclusion criteria (5 listed)
- Diaphragmatic paralysis
- Neuromuscular disease
- significant pleural effusion
- atelectasis requiring bronchoscopy
- abdominal hypertension
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 |
|---|---|---|
| Sonographic diaphragmatic measurementsAlso: Diaphragmatic excursion, Diaphragmatic thickening | Other | – |
Primary outcome
Diaphragmatic excursion
Time frame: Before the first NIV session
Diaphragmatic thickening
Time frame: Before the first NIV session
Diaphragmatic excursion
Time frame: After the first NIV session
Diaphragmatic thickening
Time frame: After the first NIV session
Diaphragmatic excursion
Time frame: After 24 h of NIV use
Diaphragmatic thickening
Time frame: After 24 h of NIV use
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 22 Mar 2018.
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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.
Gharib AJOB, MD principal investigator
Hôpitaux Universitaires de Strasbourg
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 Critical Care and Invasive Mechanical Ventilation, run by University Hospital, Strasbourg, France 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 5 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 22 Mar 2018. 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?
Diaphragmatic excursion (time frame: Before the first NIV session). The study lists 6 primary outcomes in all. 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 22 Mar 2018.