Muscle WeaknessNCT03567564
Abdominal Muscle Thickness in Mechanically Ventilated Patients
An observational study of Muscle Weakness and Weaning Failure, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 2 sites in 2 countries.
Trial summary
The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Weaning Failure
- What is being tested?
- Abdominal muscles ultrasound
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Apr 2017to 28 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients Mechanically ventilated in ICU
Who may be able to join
- greater than 18 years old
- Patients requiring invasive mechanical ventilation including patients with endotracheal tube and tracheotomies
Who cannot join
- Patients with a previously diagnosed neuromuscular disorder (acute or chronic)
- Behavioural agitation
- Patients who are not awake and cooperative
- Previously enrolled in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Abdominal Muscle Thickness in Mechanically Ventilated Patients During Spontaneous Breathing Trials
The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.
Read the detailed description
The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.
- Conditions
- Muscle Weakness, Weaning Failure
- Being tested
- Abdominal muscles ultrasound
- Keywords
- abdominal muscles, spontaneous breathing trial, critically ill patients
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal muscles ultrasoundDiagnostic test
Abdominal muscles ultrasound during a spontaneous breathing trial using the M-mode to calculate the thickening fraction of the anterior and lateral abdominal muscles under multiple circumstances (tasks performed by the patients)
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated patients | Abdominal muscles ultrasound Receives: Diagnostic Test: Abdominal muscles ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between thickening fraction and SBT outcome
Correlation between thickening fraction of each muscles evaluated by ultrasound before the SBT and the SBT outcome.
Measured: Measurements will be performed before SBT
Secondary outcomes (2)
Correlation between the pressures generated by respiratory muscles and SBT outcome
Correlation between the pressures generated by respiratory muscles during the ultrasound measurements (Twice Transdiaphragmatic pressure, TwPdi; maximal inspiratory pressure, MIP) and SBT outcome
Measured: Measurements will be performed before SBT
Inter-rater agreement
Concordance of measurements of abdominal muscle thickness and thickening fraction in mechanically ventilated patients performed by two different observers will be evaluated.
Measured: Measurements will be performed before SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start26 Apr 2017
- Primary completion30 May 2019 (estimated)
- Study completion28 Dec 2019 (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 Muscle WeaknessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Piva Simone, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Simone Piva, M.D., Study director, University Of Brescia, Spedali Civili di BresciaEwan Goligher, M.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567564
- Sponsor's protocol ID
- Abdominals
- Status last verified
- Jun 2018
- First submitted
- 2 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schreiber AF, Bertoni M, Coiffard B, Fard S, Wong J, Reid WD, Brochard LJ, Piva S, Goligher EC. Abdominal Muscle Use During Spontaneous Breathing and Cough in Patients Who Are Mechanically Ventilated: A Bi-center Ultrasound Study. Chest. 2021 Oct;160(4):1316-1325. doi: 10.1016/j.chest.2021.05.053. Epub 2021 Jun 6.
PubMed 34090872
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Muscle Thickness in Mechanically Ventilated Patients During Spontaneous Breathing Trials
- ClinicalTrials.gov ID
- NCT03567564
- Acronym / sponsor ID
- Abdominals
- Conditions
- Muscle Weakness, Weaning Failure
- Keywords
- abdominal muscles, spontaneous breathing trial, critically ill patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 28 Dec 2019 (estimated)
- First posted
- 26 Jun 2018 (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.
The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.
Detailed description
The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients | – | Diagnostic Test: Abdominal muscles ultrasoundAbdominal muscles ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Mechanically ventilated in ICU
Key inclusion criteria (2 listed)
- greater than 18 years old
- Patients requiring invasive mechanical ventilation including patients with endotracheal tube and tracheotomies
Key exclusion criteria (4 listed)
- Patients with a previously diagnosed neuromuscular disorder (acute or chronic)
- Behavioural agitation
- Patients who are not awake and cooperative
- Previously enrolled in the study
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 |
|---|---|---|
| Abdominal muscles ultrasoundAbdominal muscles ultrasound during a spontaneous breathing trial using the M-mode to calculate the thickening fraction of the anterior and lateral abdominal muscles under multiple circumstances (tasks performed by the patients) | Diagnostic test | Mechanically ventilated patients |
Primary outcome
Correlation between thickening fraction and SBT outcome
Time frame: Measurements will be performed before SBT
Correlation between thickening fraction of each muscles evaluated by ultrasound before the SBT and the SBT outcome.
2 secondary outcomes
Correlation between the pressures generated by respiratory muscles and SBT outcome
Time frame: Measurements will be performed before SBT
Inter-rater agreement
Time frame: Measurements will be performed before SBT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 34090872Schreiber AF, Bertoni M, Coiffard B, Fard S, Wong J, Reid WD, Brochard LJ, Piva S, Goligher EC. Abdominal Muscle Use During Spontaneous Breathing and Cough in Patients Who Are Mechanically Ventilated: A Bi-center Ultrasound Study. Chest. 2021 Oct;160(4):1316-1325. doi: 10.1016/j.chest.2021.05.053. Epub 2021 Jun 6.
- Individual participant dataSharing planned: Undecided
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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.
Simone Piva, M.D. study director
University Of Brescia, Spedali Civili di Brescia
Ewan Goligher, M.D. principal investigator
University of Toronto
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Weakness and Weaning Failure, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 2 sites in 2 countries.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Italy. 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?
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?
Correlation between thickening fraction and SBT outcome (time frame: Measurements will be performed before SBT). 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 NCT03567564, 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 26 Jun 2018.