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.

Study Locations

  • Canada
      • Toronto, Canada, ON M5G 2N2
        • Toronto General Hospital Research Institute
  • Italy
      • Brescia, Italy, 25100
        • Spedali Civili di Brescia

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
Diagnostic test: 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.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborators

University of Toronto

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.

General Publications

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

Keywords

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.

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