Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure
1 other identifier
observational
102
1 country
1
Brief 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). 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2017
CompletedFirst Submitted
Initial submission to the registry
May 29, 2019
CompletedFirst Posted
Study publicly available on registry
June 19, 2019
CompletedJune 19, 2019
June 1, 2019
1.1 years
May 29, 2019
June 18, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
30 days
Secondary Outcomes (1)
HGS cut-off points indicative of ICU acquired Weakness
30 days
Interventions
The overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale and Palmar dynamometer strength
Eligibility Criteria
Adult patients on invasive mechanical ventilation for more than 48 hours and ready to perform the spontaneous breathing test.
You may qualify if:
- 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
You may not qualify if:
- \- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035007, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilberto Friedman, Prof
Hospital de Clinicas de Porto Alegre
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2019
First Posted
June 19, 2019
Study Start
March 1, 2016
Primary Completion
March 30, 2017
Study Completion
April 30, 2017
Last Updated
June 19, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share