VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient (VALIDUM)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Muscle Atrophy
• Intervention / Treatment: Diagnostic test: Ultra- sound

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:

CT Images - All abdominal CT images conducted during the index hospitalization ordered for clinical purposes will be retrieved to precisely quantify muscle and adipose tissue mass.

Ultrasound - A portable ultrasound will be completed as soon as possible following the initial CT Scan, and again while a participant remains in hospital for each follow up CT of the abdomen for clinical reasons, where feasible, unless it is within a week of the previous CT scan.

Multiple Frequency Bioelectrical Impedance Analysis (MF-BIA) -MF-BIA is a non-invasive and simple-to-use method of measuring body composition and nutritional status in the clinical setting. MF-BIA measurements will be conducted every time an US measurement is done in the ICU following a CT Scan done for clinical reasons, unless it is within a week of the previous CT Scan and accompanying MF-BIA. After discharge from the ICU to the hospital, where feasible, MF BIA will be done every time an ultrasound is done following CT scans done for clinical reasons, unless it is within a week of the previous CT Scan and accompanying MF-BIA. MF-BIA will not be done on individuals with a pacemaker, Baseline patient demographics data and nutritional adequacy data will be collected.

• Study Type: Observational
• Enrollment (Actual): 204

Participation Criteria

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

This study will enroll a broad heterogeneous patient population who will be admitted to the ICU for inpatient care. We are particularly interested in the cohort of patients with trauma but will enroll non-trauma patients who have CT scans as well to do some between group comparisons.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ultra- sound; ultra- sound assessment of their quadriceps muscle layer thickness (QMLT)	Diagnostic test: Ultra- sound; Ultrasound assessment of quadricep muscle layer thickness QMLT within 72hrs of initial CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity of bedside US of QMLT	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.	12 months

Collaborators and Investigators

• Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: intensive care unit; ultrasound; computed tomography; muscle atrophy; muscle thickness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Critical Illness; Atrophy
• Other Study ID Numbers: VALIDUM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO