ICU Associated Weakness and Bedside Ultrasound Assessment

NCT04095533 | Terminated

• 1 other identifier: REB18-1859
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

ICU-associated weakness is a common experience for people following a critical illness. It is associated with important patient and system-relevant outcomes. Diagnosing ICU-associated weakness can be challenging because making the diagnosis relies on volitional participation in strength testing by the patient in a very ill population that is often sedated or restrained. This study proposes to test if bedside ultrasound of tibialis anterior (a non-invasive test that doesn't require active participation by the patient) correlates with clinical whole-body weakness in critically ill patients admitted to an ICU with sepsis.

Conditions

Sarcopenia; ICU Acquired Weakness

Keywords

critical care

Outcome Measures

Primary Outcomes (1)

• Correlation of tibialis anterior muscle atrophy development with whole-body strength

  Determine if the rates of decline of tibialis anterior muscle cross-sectional area (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate with bedside clinical measures of strength using the MRC sum score.

  First two weeks of ICU admission

Secondary Outcomes (5)

• Correlation of tibialis anterior muscle atrophy development with ankle dorsiflexion strength

  First two weeks of ICU admission

• Correlation of tibialis anterior muscle atrophy development with illness severity at admission ICU

  First two weeks of ICU admission

• Correlation of tibialis anterior muscle atrophy development with duration of mechanical ventilation in ICU

  First two weeks of ICU admission

• Correlation of tibialis anterior muscle atrophy development with ICU length of stay

  First two weeks of ICU admission

• Correlation of tibialis anterior muscle atrophy development with hospital length of stay

  First two weeks of ICU admission

Study Arms (1)

Sepsis

Starting at admission to ICU, patients admitted to a mixed medical-surgical ICU will be assessed every second day to determine their muscle size as measured by ultrasound, and their muscle strength as measured clinically using the Medical Research Council strength assessment at the bedside. One-time Measures: * Illness severity as measured by the SOFA score within the first 24 hours of admission. * duration of mechanical ventilation * duration of stay in the ICU * duration of stay in the hospital

Other: Tibialis anterior muscle cross-sectional area assessment by ultrasound; Other: Muscle strength assessment

Interventions

Tibialis anterior muscle cross-sectional area assessment by ultrasound OTHER

Assessed using bedside ultrasound with repeat assessments every second day up to 2 weeks of ICU admission, or until discharge from ICU to yield an overall rate of muscle area decline reported as a %/day average muscle atrophy rate. Tibialis anterior cross-sectional area assessments will be assessed by measurement ultrasound to both legs with portable bedside ultrasound. The cross sectional area will be measured in cm\^2 at 5 cm distal to the lateral eminence of the tibial tuberosity along the muscle belly. Image processing will be performed at the bedside using features available on the ultrasound device. Muscle boundaries will be marked on the device and the cross-sectional area (computed from the perimetral contour of the muscle section) will be determined. This process will be repeated for two times for each leg.

Sepsis

Muscle strength assessment OTHER

Assessed using clinical bedside evaluation every second day with the Medical Research Council Sum Score. This is a clinical assessment of strength of 6 different muscle groups (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors) on each side of the body and recorded as a score between 0 (flaccid) and 5 (full strength).

Sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include any adult participants that are admitted to a mixed medical-surgical ICU with a diagnosis of sepsis. There are no restrictions based on the source of the infection (e.g. upper respiratory tract infections vs. abdominal sepsis from a perforated viscous) and no restriction based on the treatment provided (e.g. surgery for source control vs. systemic antibiotics).

You may qualify if:

• adult patients (age \> 18 years);
• admitted to the ICU with a diagnosis of sepsis, and;
• an ICU duration of stay of greater than 4 days (two allow for serial assessments of muscle strength and size).

You may not qualify if:

• Any pre-existing diagnosis that would reasonably impact a participant's muscle bulk, strength, coordination, or ability to participate in the assessment
• Any activity orders or movement restrictions (including medical devices such as casts or external fixation devices) that would preclude accurate motor strength assessment.
• Dressings, casts, or medical implements that would preclude or impede ultrasound assessment of tibialis anterior muscle cross-sectional area in both legs.
• Patients who are "proned" or in positions that make assessing tibialis anterior with ultrasound or physical exam impractical.
• Re-admission to ICU within the same hospital stay.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 5A1, Canada

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: October 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 8, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)