Ventilation Therapy; ComplicationsABDO-VMNCT04939298
Ultrasound Evaluation of Abdominal Muscle Thickness During Mechanical Ventilation
A study testing Ultrasound in people with Ventilation Therapy; Complications, run by Centre Hospitalier de Roanne at 1 site in France.
Trial summary
Weakness of respiratory muscles is frequent after several days of mechanical ventilation. Thereby an acquired diaphragm weakness has been demonstrated, linked to an atrophy which may be identified by a decrease of muscle thickness in echography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2021to 16 Nov 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patient affiliated or entitled to a social security plan
- Expected duration of mechanical ventilation > 7 days
- Trusted person/relative who has signed a consent to participate in the study
Who cannot join
- Patient with a pre-existing neuromuscular pathology
- No access to ultrasound Windows (dressing, drainages...)
- Patient transferred from another intensive care unit
- Patient Under guardianship or curators
Trial locations and contacts
1 site in 1 country.
About this study
Weakness of respiratory muscles is frequent after several days of mechanical ventilation. Thereby an acquired diaphragm weakness has been demonstrated, linked to an atrophy which may be identified by a decrease of muscle thickness in echography. This study aims to evaluate with ultrasound the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.
Read the detailed description
Weakness of respiratory muscles is frequent after several days of mechanical ventilation. Thereby an acquired diaphragm weakness has been demonstrated, linked to an atrophy which may be identified by a decrease of muscle thickness in echography. Weakness of expiratory muscles is also frequent after 7 days of mechanical ventilation, however his cause is not clear: is it present at admission notably in elderly patients, or acquired on mechanical ventilation ? Ultrasound allows to measure the thickness of abdominal muscles which correlates with their strength. This study aims to evaluate with ultrasound the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.
- Conditions
- Ventilation Therapy; Complications
- Being tested
- Ultrasound
- Keywords
- abdominal muscles, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound evaluation of the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Patients under mechanical ventilation | Experimental | Ultrasound evaluation of the variation of thickness of abdominal muscles after 7 days of mechanical ventilation Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the abdominal muscles (mm)
It is the sum of the thickness of rectus abdominal muscle + external oblique + internal oblique + transverse muscles.
Measured: Day 7
Secondary outcomes (16)
Thickness of the rectus abdominal muscles (mm)
Thickness of the rectus abdominal muscles (mm) by ultrasound measurement.
Measured: Day 7
Thickness of the external oblique abdominal muscles (mm)
Thickness of the external oblique abdominal muscles (mm) by ultrasound measurement
Measured: Day 7
Thickness of the internal oblique abdominal muscles (mm)
Thickness of the internal oblique abdominal muscles (mm) by ultrasound measurement
Measured: Day 7
Thickness of the transverse abdominal muscles (mm)
Thickness of the transverse abdominal muscles (mm) by ultrasound measurement
Measured: Day 7
Diaphragmatic thickness (mm)
Diaphragmatic thickness (mm) measured by ultrasound
Measured: Day 7
Diaphragmatic thickness (mm)
Diaphragmatic thickness (mm) measured by ultrasound
Measured: Immediately after the successful extubation of the patient
Number of day with a contraction of the transverse abdominal muscle
Ultrasound search for a contraction of the transverse abdominal muscle during the morning clinical examination each day from D1 to D7
Measured: From day 1 to day 7
Caught peak expiratory flow (CPEF) (cmH2O)
Only for conscious patients, responding to the simple command and tolerating minimal respiratory support (inspiratory support 7 cmH20, Pep 0 cmH20) caught peak expiratory flow (CPEF) measurement
Measured: Day 7
Maximum expiratory pressure (l/min)
Only for conscious patients, responding to the simple command and tolerating minimal respiratory support maximum expiratory pressure (PE max) measurement
Measured: Day 7
Thickness of the external oblique abdominal muscle (mm)
External oblique abdominal muscle by ultrasound measurement
Measured: Immediately after the successful extubation of the patient
Thickness of the internal oblique abdominal muscle (mm)
Internal oblique abdominal muscle by ultrasound measurement
Measured: Immediately after the successful extubation of the patient
Thickness of the transverse abdominal muscle (mm)
Transverse abdominal muscle by ultrasound measurement
Measured: Immediately after the successful extubation of the patient
Thickness of the rectus abdominal muscle (mm)
Rectus abdominal muscle by ultrasound measurement
Measured: Immediately after the successful extubation of the patient
Number of day between day 7 and successful extubation day (days)
Measured: From Day 7 to the day when the patient will be extubated successfully
Duration of sedation (Day)
Measured: At intensive care unit discharge
Duration of curarization (Day)
Measured: At intensive care unit discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start15 Jul 2021
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Therapy; ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Roanne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
- Responsible party
- Sponsor
- Investigators
- Pascal Beuret, MD, Principal investigator, HOPITAL DE ROANNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939298
- Sponsor's protocol ID
- 2020/01
- Other IDs
- 2020-A03186-33
- Acronym
- ABDO-VM
- Status last verified
- Feb 2024
- First submitted
- 11 Jun 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Abdominal Muscle Thickness During Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04939298
- Acronym / sponsor ID
- ABDO-VM / 2020/01
- Conditions
- Ventilation Therapy; Complications
- Keywords
- abdominal muscles, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier de RoanneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 25 Jun 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.
Weakness of respiratory muscles is frequent after several days of mechanical ventilation. Thereby an acquired diaphragm weakness has been demonstrated, linked to an atrophy which may be identified by a decrease of muscle thickness in echography. This study aims to evaluate with ultrasound the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.
Detailed description
Weakness of respiratory muscles is frequent after several days of mechanical ventilation. Thereby an acquired diaphragm weakness has been demonstrated, linked to an atrophy which may be identified by a decrease of muscle thickness in echography. Weakness of expiratory muscles is also frequent after 7 days of mechanical ventilation, however his cause is not clear: is it present at admission notably in elderly patients, or acquired on mechanical ventilation ? Ultrasound allows to measure the thickness of abdominal muscles which correlates with their strength. This study aims to evaluate with ultrasound the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients under mechanical ventilation | Experimental | Device: UltrasoundUltrasound evaluation of the variation of thickness of abdominal muscles after 7 days of mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient affiliated or entitled to a social security plan
- Expected duration of mechanical ventilation > 7 days
- Trusted person/relative who has signed a consent to participate in the study
Key exclusion criteria (4 listed)
- Patient with a pre-existing neuromuscular pathology
- No access to ultrasound Windows (dressing, drainages...)
- Patient transferred from another intensive care unit
- Patient Under guardianship or curators
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 |
|---|---|---|
| UltrasoundUltrasound evaluation of the variation of thickness of abdominal muscles after 7 days of mechanical ventilation. | Device | Patients under mechanical ventilation |
Primary outcome
Thickness of the abdominal muscles (mm)
Time frame: Day 7
It is the sum of the thickness of rectus abdominal muscle + external oblique + internal oblique + transverse muscles.
16 secondary outcomes
Thickness of the rectus abdominal muscles (mm)
Time frame: Day 7
Thickness of the external oblique abdominal muscles (mm)
Time frame: Day 7
Thickness of the internal oblique abdominal muscles (mm)
Time frame: Day 7
Thickness of the transverse abdominal muscles (mm)
Time frame: Day 7
Diaphragmatic thickness (mm)
Time frame: Day 7
Diaphragmatic thickness (mm)
Time frame: Immediately after the successful extubation of the patient
Number of day with a contraction of the transverse abdominal muscle
Time frame: From day 1 to day 7
Caught peak expiratory flow (CPEF) (cmH2O)
Time frame: Day 7
Maximum expiratory pressure (l/min)
Time frame: Day 7
Thickness of the external oblique abdominal muscle (mm)
Time frame: Immediately after the successful extubation of the patient
Thickness of the internal oblique abdominal muscle (mm)
Time frame: Immediately after the successful extubation of the patient
Thickness of the transverse abdominal muscle (mm)
Time frame: Immediately after the successful extubation of the patient
Thickness of the rectus abdominal muscle (mm)
Time frame: Immediately after the successful extubation of the patient
Number of day between day 7 and successful extubation day (days)
Time frame: From Day 7 to the day when the patient will be extubated successfully
Duration of sedation (Day)
Time frame: At intensive care unit discharge
Duration of curarization (Day)
Time frame: At intensive care unit discharge
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 7 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Pascal Beuret, MD principal investigator
HOPITAL DE ROANNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Ventilation Therapy; Complications, run by Centre Hospitalier de Roanne 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 7 Feb 2024. 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?
Thickness of the abdominal muscles (mm) (time frame: Day 7). 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 7 Feb 2024.