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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Device: Cycle Ergometer; Other: Conventional physiotherapy

• Registration Number: NCT02300662
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Primary Completion: 2015-07
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cycle Ergometer	Cycle Ergometer	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
Cycle Ergometer	Conventional physiotherapy	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
Conventional Physiotherapy	Conventional physiotherapy	Upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
change in diaphragm excursion	baseline and after seven days of protocol	ultrasound measurement of the inspiratory and expiratory diaphragmatic excursion
change in diaphragm thickness	baseline and after seven days of protocol	ultrasound measurement of the diaphragm muscle thickness
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

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil