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

To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate.

Study Overview

• Status: Unknown
• Conditions: Respiratory Failure; Physical Therapy; Functional Performance

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: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

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	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	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

Outcome Measure	Measure Description	Time Frame
Correlations between the Change from Baseline 'grip - hand strength' to the timing before weaning and ventilator days	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	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	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	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

• Sponsor: Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
• O'Connor ED, Walsham J. Should we mobilise critically ill patients? A review. Crit Care Resusc. 2009 Dec;11(4):290-300.
• Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Anticipated): February 19, 2020
• Study Completion (Anticipated): February 19, 2020

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: functional performance; respiratory failure; physical therapy; weaning; mechanical ventilator; cardiopulmonary physical therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID 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