Muscle Weakness ConditionNCT03991702
Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure
An observational study of Muscle Weakness Condition and Mechanical Ventilation Complication, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The handgrip strength (HGS) will be measured with a digital dynamometer. Three measurements will be taken, whose average of the three measurements will be collected. Muscle weakness will be diagnosed based on previously published ICU acquired weakness (ICU-AW) scores (for males <11 kg and females <7 kg). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness Condition, Mechanical Ventilation Complication, Weaning Failure
- What is being tested?
- diagnostic test
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2016to 30 Apr 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients on invasive mechanical ventilation for more than 48 hours and ready to perform the spontaneous breathing test.
Who may be able to join
- age over 18 years
- being on invasive mechanical ventilation for more than 48 hours
- fulfill the pre-defined criteria for performing the spontaneous breathing test
Who cannot join
- patients unable to perform the hand grip strength test and the MRC scale (any rheumatologic conditions, neuromuscular, amputation, cachexia, neuropsychiatric symptoms: such as confusion and delirium)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035007
About this study
Official title: Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure and Duration of Mechanical Ventilation.
The handgrip strength (HGS) will be measured with a digital dynamometer. Three measurements will be taken, whose average of the three measurements will be collected.
Muscle weakness will be diagnosed based on previously published ICU acquired weakness (ICU-AW) scores (for males <11 kg and females <7 kg).
Read more
The overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale. The maximum score of the scale is 60 points, adding the degree of muscle strength of all muscle groups tested. If the patient is unable to have one of the limbs tested, it is assumed that the limb would have the same force as the contralateral limb.
A score of 48 points or less is indicative of muscle weakness. Individuals who scored between 48 and 37 points on the MRC scale are considered to have significant weaknesses; those with 36 points or less are classified as severely weak.
The HGS and the MRC scale will be compared as predictors of weaning duration of mechanical ventilation
Read the detailed description
The handgrip strength will be measured with a digital dynamometer. The patient's dominant hand will be tested, with the patient as seated as possible, with the elbow as close as to 90º. Three measurements will be taken, respecting a minute interval between them, whose average of the three measurements will be collected.
Muscle weakness will be diagnosed based on previously published weakness scores (for males <11 kg (kilograms) and females <7 kg) 25. The strength value will be normalized as a relative value in percent, calculated according to Bohannon et al. based on values of healthy individuals, considering gender and age. It will also be normalized according to height, due to the known impact of this anthropometric feature on palmar strength.
The overall motor function of the patient will be assessed using the Medical Research Council (MRC) 24 scale. The evaluation will consist of the bilateral analysis of six specific movements (shoulder abduction, elbow flexion, wrist flexion, hip flexion, knee extension, ankle dorsiflexion) through manual muscle testing, scoring from zero to five points 2 = movement without the action of gravity, 3 = movement against the action of gravity, 4 = a slight manual resistance wins, 5 = a great manual resistance wins ). The maximum score of the scale is 60 points, adding the degree of muscle strength of all muscle groups tested. If the patient is unable to have one of the limbs tested (for example: amputation) it is assumed that the limb would have the same force as the contralateral limb.
In order to standardize the position during the application of the scale and to minimize bias, the position will be adopted in the supine position, with the bed between 45º to 60º and symmetrical posture. First the patient will be asked to move freely. According to the result, manual resistance is imposed or the action of gravity is eliminated.
The indicative weakness score is 48 points or less. Individuals who score between 48 and 37 points on the MRC scale are considered to have significant weaknesses; those with 36 points or less are classified as severely weak.
The handgrip strength and the MRC scale will be compared as predictors of weaning duration of mechanical ventilation
- Being tested
- diagnostic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic testDiagnostic test
The overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale and Palmar dynamometer strength
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical ventilation weaning time
to evaluate the hand grip strength as a predictor of spontaneous breathing test failure and the duration of mechanical ventilation weaning.
Measured: 30 days
Duration of mechanical ventilation
to evaluate the Medical Research Council scale as a predictor of spontaneous breathing test failure and the duration of mechanical ventilation. The MRC score is obtained by evaluating 12 muscle groups in the upper extremities (wrist extensors, elbow flexors and abductors of the shoulder) and lower extremities (dorsal ankle flexors, knee extensors, and hip flexors). For each muscle group will be assigned a score between 0 (complete paralysis) and 5 (normal force), and the total score can vary between 0 up to 60 points.
Measured: 30 days
Secondary outcomes (1)
HGS cut-off points indicative of ICU acquired Weakness
to define HGS cut-off points indicative of ICU acquired weakness for men and women
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Mar 2016
- Primary completion30 Mar 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Weakness ConditionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilberto Friedman, Prof, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991702
- Sponsor's protocol ID
- 49900015.0.0000.5327
- Status last verified
- Jun 2019
- First submitted
- 29 May 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure and Duration of Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT03991702
- Acronym / sponsor ID
- 49900015.0.0000.5327
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 19 Jun 2019 (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.
The handgrip strength (HGS) will be measured with a digital dynamometer. Three measurements will be taken, whose average of the three measurements will be collected.
Muscle weakness will be diagnosed based on previously published ICU acquired weakness (ICU-AW) scores (for males <11 kg and females <7 kg).
The overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale. The maximum score of the scale is 60 points, adding the degree of muscle strength of all muscle groups tested. If the patient is unable to have one of the limbs tested, it is assumed that the limb would have the same force as the contralateral limb.
A score of 48 points or less is indicative of muscle weakness. Individuals who scored between 48 and 37 points on the MRC scale are considered to have significant weaknesses; those with 36 points or less are classified as severely weak.
The HGS and the MRC scale will be compared as predictors of weaning duration of mechanical ventilation
Detailed description
The handgrip strength will be measured with a digital dynamometer. The patient's dominant hand will be tested, with the patient as seated as possible, with the elbow as close as to 90º. Three measurements will be taken, respecting a minute interval between them, whose average of the three measurements will be collected.
Muscle weakness will be diagnosed based on previously published weakness scores (for males <11 kg (kilograms) and females <7 kg) 25. The strength value will be normalized as a relative value in percent, calculated according to Bohannon et al. based on values of healthy individuals, considering gender and age. It will also be normalized according to height, due to the known impact of this anthropometric feature on palmar strength.
The overall motor function of the patient will be assessed using the Medical Research Council (MRC) 24 scale. The evaluation will consist of the bilateral analysis of six specific movements (shoulder abduction, elbow flexion, wrist flexion, hip flexion, knee extension, ankle dorsiflexion) through manual muscle testing, scoring from zero to five points 2 = movement without the action of gravity, 3 = movement against the action of gravity, 4 = a slight manual resistance wins, 5 = a great manual resistance wins ). The maximum score of the scale is 60 points, adding the degree of muscle strength of all muscle groups tested. If the patient is unable to have one of the limbs tested (for example: amputation) it is assumed that the limb would have the same force as the contralateral limb.
In order to standardize the position during the application of the scale and to minimize bias, the position will be adopted in the supine position, with the bed between 45º to 60º and symmetrical posture. First the patient will be asked to move freely. According to the result, manual resistance is imposed or the action of gravity is eliminated.
The indicative weakness score is 48 points or less. Individuals who score between 48 and 37 points on the MRC scale are considered to have significant weaknesses; those with 36 points or less are classified as severely weak.
The handgrip strength and the MRC scale will be compared as predictors of weaning duration of mechanical ventilation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients on invasive mechanical ventilation for more than 48 hours and ready to perform the spontaneous breathing test.
Key inclusion criteria (3 listed)
- age over 18 years
- being on invasive mechanical ventilation for more than 48 hours
- fulfill the pre-defined criteria for performing the spontaneous breathing test
Key exclusion criteria (1 listed)
- patients unable to perform the hand grip strength test and the MRC scale (any rheumatologic conditions, neuromuscular, amputation, cachexia, neuropsychiatric symptoms: such as confusion and delirium)
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 |
|---|---|---|
| diagnostic testThe overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale and Palmar dynamometer strength | Diagnostic test | – |
Primary outcome
mechanical ventilation weaning time
Time frame: 30 days
to evaluate the hand grip strength as a predictor of spontaneous breathing test failure and the duration of mechanical ventilation weaning.
Duration of mechanical ventilation
Time frame: 30 days
to evaluate the Medical Research Council scale as a predictor of spontaneous breathing test failure and the duration of mechanical ventilation. The MRC score is obtained by evaluating 12 muscle groups in the upper extremities (wrist extensors, elbow flexors and abductors of the shoulder) and lower extremities (dorsal ankle flexors, knee extensors, and hip flexors). For each muscle group will be assigned a score between 0 (complete paralysis) and 5 (normal force), and the total score can vary between 0 up to 60 points.
1 secondary outcome
HGS cut-off points indicative of ICU acquired Weakness
Time frame: 30 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 19 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Gilberto Friedman, Prof principal investigator
Hospital de Clinicas de Porto Alegre
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 Muscle Weakness Condition and Mechanical Ventilation Complication, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 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 19 Jun 2019. 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 Brazil. 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?
mechanical ventilation weaning time (time frame: 30 days). The study lists 2 primary outcomes in all. 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 19 Jun 2019.