Mechanical VentilationWEAN USNCT03261440
Cardiac, Pulmonary and Diaphragm Sonography for the Early Diagnosis of the Different Etiologies Underlying Failure of Weaning From Mechanical Ventilation
An observational study of Mechanical Ventilation and Following Heart or Abdominal Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Weaning patients off ventilation in an ICU is sometimes difficult, because of three major inter-related etiologies: impaired lung, heart and diaphragm function. In this context, ultrasonography during tests to wean patients off ventilation could make it possible to diagnose cardiac dysfunction, a loss of pulmonary… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mechanical Ventilation, Following Heart or Abdominal Surgery
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Nov 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on post-operative mechanical ventilation following heart or abdominal surgery
Who may be able to join
- Patients on mechanical ventilation for at least 48 hours
- Age ≥ 60 years
- Patients who have undergone abdominal or heart surgery
Who cannot join
- Patients with a known neuromuscular disease
- Patients younger than 60 years
- Duration of mechanical ventilation <48h
- Non-surgical patients
- Patients with severe COPD
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Belaïd BOUHEMAD, 03 80 29 93 42 ext. +33, belaid.bouhemad@chu-dijon.fr
About this study
Official title: Combined Cardiac, Pulmonary and Diaphragm Sonography for the Evaluation of Failure in Ventilation Weaning
Weaning patients off ventilation in an ICU is sometimes difficult, because of three major inter-related etiologies: impaired lung, heart and diaphragm function. In this context, ultrasonography during tests to wean patients off ventilation could make it possible to diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus reduce the number of failures at extubation.
The study will be carried out in 100 patients on mechanical ventilation following abdominal or heart surgery, who will have echocardiography, and pulmonary and diaphragm ultrasonography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography
Measured: At baseline
Lung ultrasonography
Measured: At baseline
Diaphragm ultrasonography
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261440
- Sponsor's protocol ID
- KLEIN 2016
- Acronym
- WEAN US
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouhemad B, Mojoli F, Nowobilski N, Hussain A, Rouquette I, Guinot PG, Mongodi S. Use of combined cardiac and lung ultrasound to predict weaning failure in elderly, high-risk cardiac patients: a pilot study. Intensive Care Med. 2020 Mar;46(3):475-484. doi: 10.1007/s00134-019-05902-9. Epub 2020 Jan 8.
PubMed 31915837
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cardiac, Pulmonary and Diaphragm Sonography for the Evaluation of Failure in Ventilation Weaning
- ClinicalTrials.gov ID
- NCT03261440
- Acronym / sponsor ID
- WEAN US / KLEIN 2016
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 25 Aug 2017 (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.
Weaning patients off ventilation in an ICU is sometimes difficult, because of three major inter-related etiologies: impaired lung, heart and diaphragm function. In this context, ultrasonography during tests to wean patients off ventilation could make it possible to diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus reduce the number of failures at extubation.
The study will be carried out in 100 patients on mechanical ventilation following abdominal or heart surgery, who will have echocardiography, and pulmonary and diaphragm ultrasonography.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on post-operative mechanical ventilation following heart or abdominal surgery
Key inclusion criteria (3 listed)
- Patients on mechanical ventilation for at least 48 hours
- Age ≥ 60 years
- Patients who have undergone abdominal or heart surgery
Key exclusion criteria (5 listed)
- Patients with a known neuromuscular disease
- Patients younger than 60 years
- Duration of mechanical ventilation <48h
- Non-surgical patients
- Patients with severe COPD
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
Echocardiography
Time frame: At baseline
Lung ultrasonography
Time frame: At baseline
Diaphragm ultrasonography
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Derived from this study: PubMed 31915837Bouhemad B, Mojoli F, Nowobilski N, Hussain A, Rouquette I, Guinot PG, Mongodi S. Use of combined cardiac and lung ultrasound to predict weaning failure in elderly, high-risk cardiac patients: a pilot study. Intensive Care Med. 2020 Mar;46(3):475-484. doi: 10.1007/s00134-019-05902-9. Epub 2020 Jan 8.
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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.
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 Mechanical Ventilation and Following Heart or Abdominal Surgery, run by Centre Hospitalier Universitaire Dijon 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: status not confirmed, as of the sponsor's last update on 25 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belaïd BOUHEMAD (03.80.29.93.42 ext. +33, belaid.bouhemad@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiography (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261440, which also lists 1 linked publication.
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 25 Aug 2017.