Critical Illness
Conditions
Brief summary
A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate the effects on critical patients on invasive mechanical ventilation of early mobilization with a cycle ergometer.
Detailed description
A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate the effects on critical patients on invasive mechanical ventilation of early mobilization with a cycle ergometer. Patients (age \> 18 years) will be recruited for this study from among those admitted to the intensive care department at the Hospital de Clínicas de Porto Alegre. Eligible patients will have been on invasive mechanical ventilation for at least 24 to 48 hours, will have spent maximum of 1 week in hospital and will not exhibit any characteristics restricting lower extremity mobility. These subjects will be randomized to receive either conventional physiotherapy or conventional physiotherapy with an additional cycle ergometer intervention. The intervention will be administered passively for 20 minutes, at 20 revolutions per minute, once per day, throughout the time the patients remain on invasive mechanical ventilation.
Interventions
DEVICECycle Ergometer
Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.
OTHERConventional physiotherapy
Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients of both sexes aged \>= 18 years will be recruited from among those admitted to the Hospital de Clínicas de Porto Alegre intensive care unit and put on invasive mechanical ventilation invasive mechanical ventilation for at least 24 to 48 hours after transfer from the emergency department or wards, no more than 1 week after admission
Exclusion criteria
* neuromuscular diseases causing motor deficits, such as strokes, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis and Guillain Barré syndrome. * patients will also be excluded in the event of the following: extubation less than 48 hours after enrollment on the study * haemodynamic instability (noradrenaline \> 0.5 mc/kg/min for arterial blood pressure \> 60 mmHg) * complications during the protocol such as pneumothorax, deep vein thrombosis or pulmonary embolism * Shilley catheter in the femoral vein * reintubation * delayed weaning (3 failed spontaneous ventilation tests) * body mass index \> 35 kg/m2 * emergence of eschar in the calcaneus area during the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in cross-sectional quadriceps thickness | baseline and after seven days of protocol | ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in length of fascicle | baseline and after seven days of protocol | ultrasound measurement of the length of fascicle |
| change in pennation angle of fascicles | baseline and after seven days of protocol | ultrasound measurement of the pennation angle of fascicles |
| change in thickness of vastus lateralis muscle | baseline and after seven days of protocol | ultrasound measurement of the thickness of vastus lateralis muscle |
| change in diaphragm thickness | baseline and after seven days of protocol | ultrasound measurement of the diaphragm muscle thickness |
| change in diaphragm excursion | baseline and after seven days of protocol | ultrasound measurement of the inspiratory and expiratory diaphragmatic excursion |
Countries
Brazil
Outcome results
None listed