The Use of Musculoskeletal Ultrasound for the Detection of ICU-Acquired Weakness

NCT05048953 | Completed DMC

• 1 other identifier: IERB No 132(6-1)t2, 078/079
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Intensive Care Unit-Acquired Weakness (ICU-AW) is a clinical entity frequently encountered in critically ill patients that have both short term and long-term implications. The current gold standard of diagnosis is by assessment of manual muscle strength, using the 6-grade Medical Research Council (MRC) sum score. However, not all Intensive Care Unit (ICU) admitted patients are conscious or cooperative enough to use MRC sum score for the diagnosis of ICU-AW. Ultrasound imaging of muscles has emerged as a valid and reliable tool for providing qualitative and quantitative details about muscle disease and has been suggested as an alternative to assess ICU-AW in critically ill patients in whom the MRC cannot be assessed. This study will be a prospective observational study to evaluate the relationship between the trend of changes in muscle thickness, echogenicity and fasciculations during the first 7 days of ICU stay as measured by ultrasound and ICU-AW among critically ill patients. The study will be performed in the ICU of TU Teaching Hospital, Kathmandu, Nepal for 1 year. All newly admitted adult patients ≥ 16 years of age, expected to stay in ICU / critical care areas for at least 7 days, barring the exclusion criteria, will be included in the study and evaluated for MRC sum score and skeletal muscle thickness, echogenicity and fasciculations using ultrasound on day 1, day 4 and day 7. The measurements will then be statistically analyzed to see if there is any relationship between trend of changes in muscle thickness, echogenicity and fasciculations and ICU-AW

Conditions

ICU Acquired Weakness

Outcome Measures

Primary Outcomes (1)

• To evaluate the relationship between trend of changes in muscle thickness, echogenicity and fasciculations and ICU-AW among critically ill patients

  7 DAYS

Study Arms (2)

MRC GROUP

All newly admitted patients (shifted to ICU within 48 h of hospital admission), aged ≥ 16 years and expected to stay in ICU or critical care areas for 7 days will be included in the study after excluding those who fulfill excluding criterial. In all the participants, muscle strength will be assessed at day 1, day 4 and day 7, if the patients are awake as assessed by Richmond Agitation Sedation Scale (RASS) (19) between -1 and 1, and cooperative (20) assessed by being able to follow at least 3 out of 5 verbal commands with facial muscles (scored by the Score of 5 Questions). Assessment will be done by an ICU physician blinded to the result of ultrasound. The MRC score will be used for assessment of strength in the following six muscle groups bilaterally: wrist dorsiflexors, elbow flexors, shoulder abductors, hip flexors, knee extensors and ankle dorsiflexors. ICU-AW will be defined as MRC sum score \< 48, in accordance with the international consensus statement.(1)

Diagnostic Test: Muscle ultrasound measurements (the index test)

Muscle ultrasound measurements (the index test)

Muscle ultrasound will be performed by an ICU faculty or a DM resident of Critical care medicine (who has an experience of at least 25 muscle ultrasonography with at least 10 muscle ultrasonography performed under supervision) (21) and will be blinded to the result of MRC score of the patient. Muscle ultrasound images on day 1, day 4 and day 7 will be obtained in the participants. The following parameters will be measured by muscle ultrasound 1. Muscle thickness 2. Muscle echogenicity 3. Muscle fasciculations Muscle thick

Interventions

Muscle ultrasound measurements (the index test) DIAGNOSTIC_TEST

The following parameters will be measured by muscle ultrasound 1. Muscle thickness 2. Muscle echogenicity 3. Muscle fasciculations

MRC GROUP

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly admitted adult patients ≥ 16 years of age expected to stay in ICU / critical care areas for at least 7 days

You may qualify if:

• All newly admitted patients (shifted to ICU within 48 h of hospital admission)
• Age ≥ 16 years
• Expected to stay in ICU or critical care areas for 7 days

You may not qualify if:

• Patients with an admission diagnosis of a neuromuscular disorder
• Patients with an admission diagnosis of stroke
• Patients with an admission diagnosis of cardiac arrest
• Patients with an admission diagnosis of traumatic brain injury
• Patients with an admission diagnosis of spinal injury
• Patients with an admission diagnosis of intracerebral infection or space-occupying lesion
• Patients transferred from ICU of another hospital
• Patients with a poor pre-hospital functional status (modified Rankin \>3)
• Patients in whom no arms or no legs were available for muscle strength testing or ultrasound

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead
• Tribhuvan University Teaching Hospital, Institute Of Medicine.: collaborator

Study Sites (1)

Institute of Medicine

Kathmandu, Bagmati, 44600, Nepal

Location

Study Officials

• MOHAN SHARMA, MBBS, MD, Mch

  IOM, TUTH, MMC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DM resident

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: October 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

NE (1)