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NCT Number: NCT01769846

The Impact of Early Mobilization Protocol in Patients in the ICU

Advances in intensive care and mechanical ventilation (MV) in the past two decades have increased critically ill patient survival. However, some patients require prolonged MV (PMV) and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse effects of medications, and prolonged immobilization. Patients in the intensive care unit (ICU) are often confined to their beds, which results in inactivity, immobility, and severe osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol improves muscle thickness (MT) of the quadriceps femoris, peripheral muscle strength, perceived functional status, gait speed, quality of life, duration of mechanical ventilation, ICU length of stay of the critically ill patient.

The purpose of this study is to evaluate the effects of implementation an early mobilization protocol in critically ill patients in the Intensive Care Unit of the University Hospital of Santa Maria.

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Key information

Conditions

Muscle Weakness ICU Length of Stay Muscle Thickness of the Quadriceps Femoris Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Weaning Acceleration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (18 years of age or greater)
  • Patients in the first 24 hours of mechanical ventilation.
  • Patients in the deep sedation will be evaluated by the Richmond Agitation-Sedation Scale (score -4).
  • Hemodynamically stable.

Exclusion criteria

  • Rapidly developing neuromuscular disease
  • Evolution of brain death
  • Cardiopulmonary arrest
  • Elevated intracranial pressure
  • Ruptured/leaking aortic aneurysm
  • Acute MI before peak troponin has been reached
  • Absent lower limb
  • Pregnancy
  • Unstable fractures contributing to likely immobility
  • Hospitalization prior to ICU admission >5 days
  • Enrollment in another clinical trial

Treatment and study plan

Early mobilization protocol

Other

Patients in the treatment group additionally received a cycling exercise session 7 days a week, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH & Co. KG, Betzenweiler, Germany). The device offers the possibility to conduct passive or active cycling at six levels of increasing resistance. The aim of each session was to have the patient cycle for 30 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position.

Primary outcomes

  1. Muscle thickness (MT) of the quadriceps femoris.

    Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.

    MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).

  2. Muscle thickness (MT) of the diaphragm.

    Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.

    MT of the diaphragm will be assessed by ultrasonography (baseline and 14 day).

Secondary outcomes

  1. Rectus femoris cross-sectional area

    Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.

    Rectus femoris cross-sectional area will be assessed by ultrasonography (baseline and 14 day).

  2. Vastus intermedius, rectus femoris and diaphragm echo intensity.

    Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.

    Vastus intermedius, rectus femoris and diaphragm echo intensity will be assessed by ultrasonography (baseline and 14 day)

  3. Rectus femoris and vastus intermedius thickness.

    Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.

    Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography (baseline and 14 day).

  4. Muscle strength

    Time frame: First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month.

    Muscle strength in arms and legs will be measured by the Medical Research Council (MRC) scale.

  5. Gait speed

    Time frame: Study completion, an average of 2 months (hospital discharge)

    Gait speed will be measured by the six-meter gait speed test (GST)

  6. Peripheral muscle strength of the lower limbs

    Time frame: Study completion, an average of 2 months (hospital discharge)

    Peripheral muscle strength of the lower limbs will be measured by 30 second chair stand test

  7. Quality of life following hospital discharge

    Time frame: Three months after hospital discharge SF36

    Quality of life will be measured by a questionnaire 36-item Short Form Health Survey

  8. Mortality

    Time frame: Patients will be followed until three months after hospital discharge

  9. ICU length of stay

    Time frame: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks.

  10. Weaning Acceleration

    Time frame: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks

  11. Side effects of mobilization protocol

    Time frame: During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.

    Haemodynamic response to mobilization. Response in systolic and diastolic blood pressure. Response in heart rate. Response in peripheral oxygen saturation.

  12. Length of hospital stay

    Time frame: Patients will be followed until hospital discharge, an expected 4 to 6 weeks

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Maria

Other

Registry information

Official study title

The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2013
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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