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出境医 / 临床实验 / Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure

Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure

Study Description
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


Condition or disease Intervention/treatment
Muscle Weakness Condition Mechanical Ventilation Complication Weaning Failure Diagnostic Test: diagnostic test

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
Layout table for study information
Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure and Duration of Mechanical Ventilation.
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : April 30, 2017
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. HGS cut-off points indicative of ICU acquired Weakness [ Time Frame: 30 days ]
    to define HGS cut-off points indicative of ICU acquired weakness for men and women


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 29, 2019
First Posted Date June 19, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date March 1, 2016
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 18, 2019)
HGS cut-off points indicative of ICU acquired Weakness [ Time Frame: 30 days ]
to define HGS cut-off points indicative of ICU acquired weakness for men and women
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure
Official Title Hand Grip Strength and Medical Research Council Scale as Predictors of Weaning Failure and Duration of Mechanical Ventilation.
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

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients on invasive mechanical ventilation for more than 48 hours and ready to perform the spontaneous breathing test.
Condition
  • Muscle Weakness Condition
  • Mechanical Ventilation Complication
  • Weaning Failure
Intervention Diagnostic Test: diagnostic test
The overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale and Palmar dynamometer strength
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 18, 2019)
102
Original Actual Enrollment Same as current
Actual Study Completion Date April 30, 2017
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- 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)

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03991702
Other Study ID Numbers 49900015.0.0000.5327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor Hospital de Clinicas de Porto Alegre
Collaborators Not Provided
Investigators
Principal Investigator: Gilberto Friedman, Prof Hospital de Clinicas de Porto Alegre
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date June 2019