Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit

Critical Illness Clinical Trial

— MoVe-ICU  

Official title:

Early Mobilization With a Cycle Ergometer for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit (MoVe-ICU Study): Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300662
• Other study ID #: 10-0530
• Status: Completed
• Phase: N/A
• First received: October 30, 2014
• Last updated: August 19, 2015
• Start date: January 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Cycle Ergometer
Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.

Other:
• Conventional physiotherapy
Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cross-sectional quadriceps thickness	ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness	baseline and after seven days of protocol	No
Secondary	change in length of fascicle	ultrasound measurement of the length of fascicle	baseline and after seven days of protocol	No
Secondary	change in pennation angle of fascicles	ultrasound measurement of the pennation angle of fascicles	baseline and after seven days of protocol	No
Secondary	change in thickness of vastus lateralis muscle	ultrasound measurement of the thickness of vastus lateralis muscle	baseline and after seven days of protocol	No
Secondary	change in diaphragm thickness	ultrasound measurement of the diaphragm muscle thickness	baseline and after seven days of protocol	No
Secondary	change in diaphragm excursion	ultrasound measurement of the inspiratory and expiratory diaphragmatic excursion	baseline and after seven days of protocol	No