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.
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
Show all 9Show fewer
- 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.
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
- Muscle thickness
- Muscle echogenicity
- 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.
- Conditions
- ICU Acquired Weakness
- 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
- Muscle thickness
- Muscle echogenicity
- Muscle fasciculations
| Study group | Role | What they receive |
|---|---|---|
| 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) 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.
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.
- First posted17 Sep 2021
- Study start1 Oct 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Responsible party
- Principal investigator, Dr Sabin Bhandari, Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Investigators
- MOHAN SHARMA, MBBS, MD, Mch, Study director, IOM, TUTH, MMC
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Changes in Thickness, Echogenicity and Fasciculation of Skeletal Muscle and Intensive Care Unit - Acquired Weakness
- ClinicalTrials.gov ID
- NCT05048953
- Acronym / sponsor ID
- IERB No 132(6-1)t2, 078/079
- Conditions
- ICU Acquired Weakness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Collaborators
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Muscle thickness
- Muscle echogenicity
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRC GROUP | – | Diagnostic Test: Muscle ultrasound measurements (the index test)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. The following parameters will be measured by muscle ultrasound 1. Muscle thickness 2. Muscle echogenicity 3. Muscle fasciculations Muscle thick |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- All newly admitted patients (shifted to ICU within 48 h of hospital admission)
Key exclusion criteria (9 listed)
- Patients with an admission diagnosis of a neuromuscular disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle ultrasound measurements (the index test)The following parameters will be measured by muscle ultrasound 1. Muscle thickness 2. Muscle echogenicity 3. Muscle fasciculations | Diagnostic test | MRC GROUP |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for ICU Acquired Weakness
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Not yet recruiting
Evidence-based, Customized, Motion-recognition Rehabilitation System Development for Bed-ridden Patients - Validation of Effectiveness: Rehabit: Swim
ICU-acquired Weakness
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruiting
Beyond Voluntary Effort: Reliability and Validity of Magnetic Femoral Nerve Stimulation for Assessing Quadriceps Strength in Critically Ill Patient
Critical Illness, ICU-acquired Weakness
Recruiting
Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility
Hospitalized Patients, ICU Hospitalization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MOHAN SHARMA, MBBS, MD, Mch study director
IOM, TUTH, MMC
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.