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ICU Acquired WeaknessNCT05048953

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

An observational study of ICU Acquired Weakness, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
ICU Acquired Weakness
What is being tested?
Muscle ultrasound measurements (the index test)
How many people
114 participants
Where
1 siteNepal
Study dates
1 Oct 2021to 1 Nov 2022
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Nepal1 site
  • Institute of Medicine

    Kathmandu, Bagmati, 44600

Other trials in Nepal

About this study

Official title: The Relationship Between Changes in Thickness, Echogenicity and Fasciculation of Skeletal Muscle and Intensive Care Unit - Acquired Weakness

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

Read the detailed description

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) 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, using Mindray DC-60® portable ultrasound machine, with a 9 to 13 MHz linear probe. The device settings include MSK pre-set, and will be kept constant during all examinations. The depth can be altered individually when deeper view is required to visualize the entire muscle thickness. Patients will be examined in the supine position with extended upper, lower limbs and completely relaxed muscles. The relaxation of muscle will be ensured by scanning the muscle in the sagittal view. A contracted muscle will show bulging in the central portion with thinning of its more distal ends. The angle of pennation can be seen to change as the muscle moves through its range of motion and the interosseous membrane will show bulging. A generous amount of contact gel will be used to minimize the required pressure of the transducer on the skin. Compression of the tissue will be avoided as it can affect the quality of muscle images. Transverse images of each muscle will be obtained with the transducer perpendicular to the direction of muscle fibre orientation.

The following parameters will be measured by muscle ultrasound

  1. Muscle thickness
  2. Muscle echogenicity
  3. Muscle fasciculations Muscle thickness Measurements will be made using the built-in electronic calipers on a frozen, real time, cross section image over the largest bulk visible to eye. 3 measurements will be taken at each site and the mean value used for statistical analysis. The following anatomical sites will be assessed bilaterally: (22)
  • The biceps brachii muscle including the underlying brachialis muscle
  • The forearm flexor group
  • The quadriceps femoris muscle
  • The tibialis anterior muscle Muscle echogenicity The muscle echogenicity will be assessed by muscle ultrasound and graded according to Heckmatt and colleagues into four grades:(16) Grade I: Normal echo intensity with starry-night aspect with distinct bone echo.

Grade II: Increased echo intensity with normal bone echo. Grade III: Increased echo intensity with reduced bone signal. Grade IV: Increased echo intensity and loss of bone signal Muscle fasciculations The muscle fasciculations will be detected by ultrasound.(18) Each muscle will be examined over a time period of 10 seconds. The movement of fasciculation will be defined as twitching of small parts of the muscle lasting for 0.2-0.5 s, at least two of which will be required to be classified as being present. A fasciculation score ranges from 0 to 4 which is the number of regions with fasciculations out of four muscle regions. All the participants will be managed according to the ICU protocol of TUTH and there will be no variation in treatment between those allocated to study and those not allocated to the study.

Being tested
Muscle ultrasound measurements (the index test)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
Study groups in NCT05048953
Study groupRoleWhat they receive
MRC GROUPAll 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)
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 7 DAYS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start1 Oct 2021
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
114 participants (actual)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05048953
Sponsor's protocol ID
IERB No 132(6-1)t2, 078/079
Status last verified
Dec 2023
First submitted
9 Sep 2021
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of ICU Acquired Weakness, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the relationship between trend of changes in muscle thickness, echogenicity and fasciculations and ICU-AW among critically ill patients (time frame: 7 DAYS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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