Diaphragm and limb muscle changes during intensive care

Not Applicable

• Conditions: Diaphragm changes; Musculoskeletal muscle changes; Mechanical Ventilation; Respiratory - Other respiratory disorders / diseases; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12618001733268
• Lead Sponsor: St Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-22
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Age >18 years
2. Anticipated treatment duration of mechanical ventilation (MV) for more than 48-hours.

Exclusion Criteria

Individuals with spinal cord injury, other primary neuromuscular diseases or new intracranial processes, amputations, previously wheelchair/bed bound, disseminated cancer and lower limb trauma. Body habitus preventing ultrasound imaging with >40 BMI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragm measures of thickness and excursion (composite outcomes) will be collected using ultrasound. This will be achieved by recording still images using a curved probe sub-costally and a linear probe anterolaterally on the chest wall and using digital callipers to measure. [Within 24hrs of mechanical ventilation, then on Day 5, 7, 10 and weekly for up to 12 months or until liberation from mechanical ventilation. Diaphragm measurements will also be taken at the point of liberation from mechanical ventilation. ];Still images of the rectus femoris muscle will be taken with ultrasound using a linear probe. Composite outcomes of cross sectional area, fascicle length and pennation angle, thickness will be calculated using digital callipers[Collected within 24hrs of commencing mechanical ventilation, then on day 5, 7, 10 and weekly for up to 12 months or until liberation from mechanical ventilation. Rectus Femoris measurements will also be taken at the point of liberation from mechanical ventilation.]

Secondary Outcome Measures

Name	Time	Method
ICU acquired Weakness will be measured using the Medical Research Council sum score (MRC-SS). This is a measure of muscle strength (manual muscle test) of major muscle groups, with ICU acquired weakness defined as a score of less than 48/60.[Measured at two timepoints: the time of patient awakening and then discharge from ICU];The Chelsea Critical Care Physical Assessment Tool (CPAx).<br>This tool measures physical and respiratory function ranging from complete dependence to independent.[Measured at the time of patient awakening and at the time of discharge from ICU]