Clinical trial NCT03894293: Correlations Among Functional Performance, Muscle Strength and Weaning Rate in Mechanically Ventilated Patients
Official title: Correlations Among Functional Performance, Muscle Strength and Weaning Rate in Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Functional Performance
Physical Therapy
Keywords: functional performance
respiratory failure
weaning
mechanical ventilator
physical therapy
cardiopulmonary physical therapy
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Respiratory failure with mechanical ventilator user

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: correlations between the Change from Baseline 'de Morton Mobility Index (DEMMI)' to the timing before weaning and the ventilator days
timeFrame: from baselineto the timing before weaning
measure: Correlations between the Change from Baseline 'Functional Status Score for the ICU (FSS-ICU)' to the timing before weaning and the ventilator days
timeFrame: from baselineto the timing before weaning
Secondary outcomes:
measure: Correlations between the Change from Baseline 'grip - hand strength' to the timing before weaning and ventilator days
timeFrame: from baselineto the timing before weaning
measure: Correlation between the Change from Baseline 'Medical Research Council (MRC) scale' to the timing before weaning and ventilator days
timeFrame: baseline, before weaning
measure: Correlations between the Change from Baseline 'Maximal inspiration pressure(PI)' to the timing before weaning and ventilator days
timeFrame: from baselineto the timing before weaning
measure: Correlation between the Change from Baseline 'Maximal expiration pressure(PE)' to the timing before weaning and ventilator days
timeFrame: from baselineto the timing before weaning
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
citation: O'Connor ED, Walsham J. Should we mobilise critically ill patients? A review. Crit Care Resusc. 2009 Dec;11(4):290-300.
citation: 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.
citation: 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.