Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Critically Ill
- Sponsor
- Australian and New Zealand Intensive Care Research Centre
- Enrollment
- 50
- Locations
- 5
- Primary Endpoint
- Highest daily level of activity measured using the ICU mobillity scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their care. They develop muscle weaknesses even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital, delay functional recovery and delay their return home and to work. Weakness may be avoided with simple strategies of early exercise in ICU. This pilot study aims to test the hypothesis that early mobilisation may improve functional recovery in this patient group and gather pilot data to support a larger randomised trial across Australia and New Zealand.
Detailed Description
Patients who are admitted and treated in the intensive care unit (ICU) generally have potentially reversible critical illness. While many patients survive, substantial proportions of patients fail to recover completely and do not return to their pre-morbid level of health. Critically ill patients receive mechanical ventilation, as a lifesaving intervention, but this is routinely managed with deep sedation and immobility, which results in prolonged periods of bed rest. Severe muscle weakness, termed ICUAW, is common and associated with prolonged duration of mechanical ventilation and hospital stay in the ICU, as well as poor recovery of physical function. Early mobilisation, exercising patients while they are still receiving mechanical ventilation, has been proposed as a candidate intervention to prevent ICU acquired weakness (ICUAW). Observational studies indicate that early mobilisation is not used routinely in critically ill patients in Australia and New Zealand. TEAM is a pilot RCT designed to obtain data to assist in the planning of an adequately powered RCT that will test the hypothesis that early mobilisation of critically ill patients improves one or more functional outcomes, quality of survival, and proportion of patients who survive.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults \> or + to 18 years old admitted to the ICU
- •Invasively ventilated and expected to be ventilated the day after tomorrow
- •Written informed consent from person responsible/ net of kin (or consent as per individual HREC if delayed or telephone consent is acceptable)
Exclusion Criteria
- •INSTABILITY A. Cardiovascular
- •Unresolved rhythm disturbance with any bradycardia requiring pharmacological support
- •Any tachycardia with ventricular rate \> 150 beats/min
- •Lactacte \> 4.0 due to inadequate tissue perfusion
- •Any external mechanical cardiovascular support (eg. VA ECMO or intra-aortic balloon pump)
- •Norad \> 0.2mcg/kg/min (or unit equivalent) or any dose of norad between 0.1 and 0.2mcg/kg/min with more than a 25% increase in last 6 hours
- •Cardiac index \< 2.0L/min/m\^2
- •B. Respiratory
- •FiO2 \> 0.6
- •PEEP \> 15
Outcomes
Primary Outcomes
Highest daily level of activity measured using the ICU mobillity scale
Time Frame: Duration of ICU stay (an average of 10 days)
ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)
Total Duration of Active Mobilisation
Time Frame: Randomisation to ICU discharge, an average of 10 days
Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours
Mean (or Median) Daily Duration of Active Mobilisation
Time Frame: Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days
Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)
Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day
Time Frame: Randomisation to Extubation, an average of 7 days
Measured using the ICU mobility scale (0-10)
Secondary Outcomes
- Physical Function(At 6 months from randomisation)
- Recruitment Rates(Entirety of Study)
- Staff Utilisation Costs(ICU admission (approximately 10 days))
- Ventilator and IC free days at Day 28(Randomisation to Day 28)
- Health related quality of life(6 Months after ICU admission)
- Return to previous work level(At 6 months from randomisation)