Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit (MoVe-ICU)

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Critical Illness

Treatments: Other: Conventional physiotherapy; Device: Cycle Ergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT02300662

10-0530

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Cycle Ergometer

Experimental group

Description:

Conventional physiotherapy and cycle ergometer 20 minutes, at 20 cycles per minute, once per day for as long as they remain on invasive mechanical ventilation

Treatment:

Device: Cycle Ergometer

Other: Conventional physiotherapy

Conventional Physiotherapy

Sham Comparator group

Description:

Upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises.

Treatment:

Other: Conventional physiotherapy