Heart SurgeryDDNCT03295344
Study of Diaphragm Mobility on Tissue Doppler
An observational study of Heart Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery. In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Surgery
- What is being tested?
- Diaphragm ultrasonography and Tissue Doppler
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2017to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in the post-operative period following heart surgery
Who may be able to join
- Post-operative period following heart surgery
Who cannot join
- Patients younger than 18 years old
- Existence of a neuro-muscular disease
- Widened surgical approach
- Refusal of the patient
- Impossibility to see diaphragm movement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)
Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.
In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Its use in the analysis of diaphragm function must be evaluated to determine its interest as a diagnostic tool.
Better understanding of diaphragm dysfunction following heart surgery will lead to earlier management of post-operative respiratory complications and the implementation of preventive pre-operative measures.
We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in the assessment of diaphragm mobility.
- Conditions
- Heart Surgery
- Being tested
- Diaphragm ultrasonography, Tissue Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm ultrasonographyOther
Spontaneously breathing patients in the ½ seated position Heart transducer at the medio axillary position, parallel to the axis of the body, last intervertebral spaces
US mode:
2D = Evaluation of the pulmonary parenchyma Time-Movement (TM) = Evaluation of diaphragm muscle shortening in the apposition zone + Evaluation of diaphragm mobility in the posterior 1/3 of the diaphragm dome Tissue Doppler Imaging (TDI) = Evaluation of diaphragm mobility in the diaphragm dome Collection of different daily clinical data
Tissue DopplerOther
Determine the threshold value for diaphragm mobility
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Diaphragm ultrasonography | |
| Healthy volunteers | Not described Receives: Other: Tissue Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure diaphragm movement in TM (Time-Movement), in tissue Doppler
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 posted27 Sep 2017
- Study start2 May 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- 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
- 170 participants (actual)
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
- NCT03295344
- Sponsor's protocol ID
- BOUARD ELLOUZE 2016
- Acronym
- DD
- Status last verified
- Feb 2023
- First submitted
- 25 Sep 2017
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)
- ClinicalTrials.gov ID
- NCT03295344
- Acronym / sponsor ID
- DD / BOUARD ELLOUZE 2016
- Conditions
- Heart Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Sep 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.
Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.
In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Its use in the analysis of diaphragm function must be evaluated to determine its interest as a diagnostic tool.
Better understanding of diaphragm dysfunction following heart surgery will lead to earlier management of post-operative respiratory complications and the implementation of preventive pre-operative measures.
We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in the assessment of diaphragm mobility.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Diaphragm ultrasonography |
| Healthy volunteers | – | Other: Tissue Doppler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the post-operative period following heart surgery
Key inclusion criteria (1 listed)
- Post-operative period following heart surgery
Key exclusion criteria (5 listed)
- Patients younger than 18 years old
- Existence of a neuro-muscular disease
- Widened surgical approach
- Refusal of the patient
- Impossibility to see diaphragm movement
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 |
|---|---|---|
| Diaphragm ultrasonographySpontaneously breathing patients in the ½ seated position Heart transducer at the medio axillary position, parallel to the axis of the body, last intervertebral spaces US mode: 2D = Evaluation of the pulmonary parenchyma Time-Movement (TM) = Evaluation of diaphragm muscle shortening in the apposition zone + Evaluation of diaphragm mobility in the posterior 1/3 of the diaphragm dome Tissue Doppler Imaging (TDI) = Evaluation of diaphragm mobility in the diaphragm dome Collection of different daily clinical data | Other | Patients |
| Tissue DopplerDetermine the threshold value for diaphragm mobility | Other | Healthy volunteers |
Primary outcome
Measure diaphragm movement in TM (Time-Movement), in tissue Doppler
Time frame: At baseline
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 28 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart 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 1 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 28 Feb 2023. 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?
Measure diaphragm movement in TM (Time-Movement), in tissue Doppler (time frame: At baseline). 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 28 Feb 2023.