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

June 18, 2019 updated by: Hospital de Clinicas de Porto Alegre

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).

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035007
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gilberto Friedman, Prof, Hospital de Clínicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 49900015.0.0000.5327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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