Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory Failure
Conditions
Brief summary
Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the ICU. Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed cycling each day they are in the ICU or routine physiotherapy, both delivered by specially trained physiotherapists. Outcomes: Feasibility: The investigators will study whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether investigators can systematically assess patients' strength. Relevance: Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized study is the second of several future larger studies about in-bed cycling in the ICU. Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).
Interventions
DEVICEIn-bed cycle ergometer (Restorative Therapies RT300 Supine)
activities to assist with optimizing airway clearance and respiratory function, and, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out of bed mobility, and ambulation
Sponsors
St. Joseph's Healthcare Hamilton
Hamilton Health Sciences Corporation
Technology Evaluation in the Elderly Network / Canadian Frailty Network
Canadian Institutes of Health Research (CIHR)
Ontario Lung Association
Canadian Respiratory Research Network
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults admitted to a medical-surgical ICU within the 1st 4 days of mechanical ventilation (MV) and 1st 7 days of ICU, and * could ambulate independently before hospital admission.
Exclusion criteria
* Acute condition impairing patients' ability to cycle (e.g., leg fracture), * proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or Guillain-Barré syndrome), * unable to follow commands in English pre-ICU, * temporary pacemaker, * expected hospital mortality \>90%, * unable to fit the bike, palliative goals of care, or persistent therapy exemptions in the 1st 4 days of MV (e.g., cardiorespiratory instability, active major bleeding)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient accrual | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cycling protocol violations (% cycling protocol violations) | 2 years | % cycling protocol violations |
| Outcome measure ascertainment (% outcomes measured in hospital) | 2 years | % outcomes measured in hospital |
| Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors) | 2 years | % outcomes at hospital discharge measured by blinded outcome assessors |
| Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge | From study admission to approximately 5, 12, 15 and 30 days, on average, respectively | Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function |
| Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale) | From study admission to approximately 12 and 30 days, on average, respectively | The patient exerts a force against a small strain gauge that fits in the examiner's hand. . |
| 2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge | From study admission to approximately 12 and 30 days, on average, respectively | Maximum distance walked in 2 minutes measured in metres on a continuous scale |
| Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge | From study admission to approximately 5, 12, 15 and 30 days, on average, respectively | Manual muscle testing using the Medical Research Council (MRC) Scale. The patient exerts a force against the examiner's resistance. Each muscle is assessed on a 6-point MRC scale (0=no contraction; 5=contraction sustained against maximal resistance). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Katz Activities of Daily Living Scale at ICU and hospital discharge | From study admission to approximately 12 and 30 days, on average, respectively | The patient's ability to complete 6 tasks: bathing, dressing, toileting, feeding, continence, and bed mobility. A rater assesses whether the patient is dependent or independent according to pre-specified criteria. |
| Euro-QOL 5DL | From study admission to approximately 12 and 30 days, on average, respectively | 5 question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/ depression, as well as a global assessment of health |
Countries
Australia, Canada, United States
Outcome results
None listed