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Clinical Trials/NCT04676464
NCT04676464CompletedNot Applicable

VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient: The VALIDUM Study

Clinical Evaluation Research Unit at Kingston General Hospital0 sites204 target enrollmentStarted: December 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
204
Primary Endpoint
Validity of bedside US of QMLT

Study Overview

Brief Summary

The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons.

The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.

Detailed Description

The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons.

The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.

This is a multi center, prospective, observation study across 5-6 intensive care units which will enroll 200 participants over a 12 month enrollment period followed by a 6 month period to complete data analysis.

This study will enroll a broad heterogeneous participant population who will be admitted to the ICU for inpatient care. We are particularly interested in the cohort of participant with trauma but will enroll non-trauma participants who have CT scans as well to do some between group comparisons. Participants enrolled to this study will be followed until they are discharged from the index hospital.

This is a prospective, observational study therefore no specific interventions will be associated with this study. The following information will be collected and recorded during ICU and hospital stay:

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Abdominal CT scan performed for clinical reasons within 24 hours before or 72 hours after admission

Exclusion Criteria

  • Patients under age 18 years
  • Moribund patient with devastating injuries and not expected to survive
  • Patients whose clinical condition precludes performing an ultrasound
  • Pregnant women
  • Prisoners
  • Mentally-disabled individuals

Outcomes

Primary Outcomes

Validity of bedside US of QMLT

Time Frame: 12 months

To evaluate the validity and reliability of bedside US by comparing measurements from US and to those estimates of lean body mass obtained from CT Scan of abdomen.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daren K. Heyland

Director of Clinical Evaluation Research Unit

Queen's University

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