Abdominal Muscle Thickness in Mechanically Ventilated Patients
June 22, 2018 updated by: Piva Simone, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients Mechanically ventilated in ICU
Description
Inclusion Criteria:
- greater than 18 years old
- Patients requiring invasive mechanical ventilation including patients with endotracheal tube and tracheotomies
Exclusion Criteria:
- Patients with a previously diagnosed neuromuscular disorder (acute or chronic)
- Behavioural agitation
- Patients who are not awake and cooperative
- Previously enrolled in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Mechanically ventilated patients
Abdominal muscles ultrasound
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measurements will be performed before SBT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between the pressures generated by respiratory muscles and SBT outcome
Time Frame: Measurements will be performed before SBT
|
Correlation between the pressures generated by respiratory muscles during the ultrasound measurements (Twice Transdiaphragmatic pressure, TwPdi; maximal inspiratory pressure, MIP) and SBT outcome
|
Measurements will be performed before SBT
|
|
Inter-rater agreement
Time Frame: Measurements will be performed before SBT
|
Concordance of measurements of abdominal muscle thickness and thickening fraction in mechanically ventilated patients performed by two different observers will be evaluated.
|
Measurements will be performed before SBT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Simone Piva, M.D., University Of Brescia, Spedali Civili di Brescia
- Principal Investigator: Ewan Goligher, M.D., University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2017
Primary Completion (Anticipated)
May 30, 2019
Study Completion (Anticipated)
December 28, 2019
Study Registration Dates
First Submitted
June 2, 2018
First Submitted That Met QC Criteria
June 13, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 22, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Abdominals
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.