Correlations Among Functional Performance, Muscle Strength and Weaning Rate in Mechanically Ventilated Patients

March 26, 2019 updated by: Taipei Veterans General Hospital, Taiwan
To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate.

Study Overview

Status

Status

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

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.

Detailed Description

To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate. Investigators use the DEMMI and FSS-ICU to evaluation the physical functional performance. And MRC score and hand dynamometer to record the muscle strength. The weaning parameters include Pi, PE, RSI,minute ventilation, tidal volume and cuff leak will be recorded. After the participant enters the Respiration Care Center, Doctor and physical therapist evaluate the consciousness and meet the inclusion criteria and the participant will received the first evaluation. The second evaluation will be held before the ventilator weaning timing.

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 (Anticipated)

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.
50

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Wan-Ting Chu, master

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Respiratory failure with mechanical ventilator user

Description

Inclusion Criteria:

  • respiratory failure with mechanical ventilator use
  • 48 hours after transferring to respiratory care center
  • consciousness clear and can obey orders
  • vital signs stable

Exclusion Criteria:

  • conscious disturbance
  • neuromuscular disease
  • stroke
  • fracture
  • patho fracture
  • BMI>45

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
ventilator group
It's a observational study. Participants entry the Respiratory Care Center and are evaluated. If the participant meet the inclusion criteria, the first assessments will be collected. After the weaning training, the second assessment will be collected before the the endotracheal tube is removed.

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
correlations between the Change from Baseline 'de Morton Mobility Index (DEMMI)' to the timing before weaning and the ventilator days
Time Frame: from baselineto the timing before weaning
Correlations between the Functional physical performance and the ventilator days.It contains 5 items including bed skill, chair skills, static balance, walking and dynamic balance. The scores of 'bed', 'chair', 'static balance', 'walking' range from 0 to 4. And the score of 'dynamic balance' range from o to 3. The sum of 5 items is total raw score. Total Raw score is 0 to 19. And raw score can be converted to DEMMI score, ranging from 0 to 100. Higher values represent better mobility performance.
from baselineto the timing before weaning
Correlations between the Change from Baseline 'Functional Status Score for the ICU (FSS-ICU)' to the timing before weaning and the ventilator days
Time Frame: from baselineto the timing before weaning
Correlations between the Functional physical performance and the ventilator days.It contains 5 items including rolling, supine-to-sit, unsupported sit, sit-to-stand and ambulation. The scores of 5 items range from 0 to 7. 0 means unable to perform; 1 means total assistance; 2 means maximum assistance; 3 means moderate assistance; 4means minimal assistance; 5 means supervision; 6 means moderate independence and 7 means complete independence. The total score ranges from 0 to 35. Higher values represent better functional performance.
from baselineto the timing before weaning

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
Correlations between the Change from Baseline 'grip - hand strength' to the timing before weaning and ventilator days
Time Frame: from baselineto the timing before weaning
Correlations between the hand strength and ventilator days. The measurement unit is kilogram(kg). The measurement tool is Jamar® Plus+ Digital Hand Dynamometer. Participant is required to use the best effort to squeeze 15 seconds and repeat 3 times. Resting time is 30 seconds. Investigators record the data and calculate the average data.
from baselineto the timing before weaning
Correlation between the Change from Baseline 'Medical Research Council (MRC) scale' to the timing before weaning and ventilator days
Time Frame: baseline, before weaning
Muscle strength assessment. 'Medical Research Council (MRC) scale' is an assessment tool of limb muscle strength. Left and Right sides are all tested. The Upper limb muscle tests include 'shoulder abduction', 'elbow flexion' and 'wrist extension. The lower limb muscle tests include 'hip flexion', 'knee extension' and 'ankle dorsiflexion'. The grades range from 0 to 5. Grade 0 means 'no contraction visible or palpable'; Grade 1 means 'flick of contraction visible or palpable, although no limb movement'; Grade3 means 'movement with gravity eliminated over almost full range of motion'; Grade 4 means 'movement against moderate resistance over full range of motion'; Grade 5 means 'normal power'. The sum of 6 items are total strength score which ranges from 0 to 60. Higher value represents better muscle strength. If the sum is below 48 points, it represents critical illness.
baseline, before weaning
Correlations between the Change from Baseline 'Maximal inspiration pressure(PI)' to the timing before weaning and ventilator days
Time Frame: from baselineto the timing before weaning
Evaluate the inspiratory muscle strength.Instruct the participants exhale slowly and completely, and then try to breath in as hard as possible. The participants should maintain inspiratory pressure for at least 1.5 seconds and the largest negative pressure sustained for at least one second should be recorded. The unit is cm H2O. Higher value represent better inspiratory muscle strength.
from baselineto the timing before weaning
Correlation between the Change from Baseline 'Maximal expiration pressure(PE)' to the timing before weaning and ventilator days
Time Frame: from baselineto the timing before weaning
Evaluate the inspiratory muscle strength.Instruct the participants inhale slowly and completely, and then try to breath out as hard as possible. The participants should maintain expiratory pressure for at least 1.5 seconds and the largest positive pressure sustained for at least one second should be recorded. The unit is cm H2O. Higher value represent better expiratory muscle strength.
from baselineto the timing before weaning

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.
Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
February 20, 2019

Primary Completion (Anticipated)

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.
February 19, 2020

Study Completion (Anticipated)

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.
February 19, 2020

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).
March 22, 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.
March 26, 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.
March 28, 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.
March 28, 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.
March 26, 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.
March 1, 2019

More Information

Terms related to this study

Keywords

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.
  • 2019-02-006C

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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