Critical Care, Intensive Care Unit Acquired Weakness, Mechanical Ventilation, Respiratory Failure
Conditions
Keywords
mechanical ventilation, cycle ergometry, intensive care unit, rehabilitation
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 vulnerable to weakness and disability. 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 employs special equipment that attaches to a patient's hospital bed, allowing them gentle leg exercise while in the ICU. The investigators will offer patients in-bed cycling while they are needing a breathing machine, to help them recover from weakness as fast as possible. Before doing a larger trial testing if in-bed cycling reduces disability, data on safety (Is it safe?) and feasibility (Can the investigators do it?) are needed. Objectives: To study the safety and feasibility of in-bed leg cycling in critically ill patients who need breathing machines. Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Specially trained physiotherapists will provide patients with 30 minutes of in-bed cycling each day while they are in the ICU. Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of patients doing in-bed cycling, while carefully monitoring for safety. (2) Feasibility: 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 the investigators can assess patients' strength in the ICU and at hospital discharge. Relevance: As the Canadian population ages, the demand for breathing machines during acute illness will increase dramatically. Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot study is the first of several future larger studies about in-bed cycling in the ICU. This program of research will help patients needing life support to regain their strength and recover as fast as possible from critical illness.
Interventions
DEVICEIn-bed leg cycle ergometry
Patients will receive 30 minutes of in-bed leg cycling in addition to routine physiotherapy, 6 days per week, for the duration of their ICU stay (to a maximum of 28 days).
Sponsors
St. Joseph's Healthcare Hamilton
McMaster University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥18 years old * Invasively mechanically ventilated ≤4 days * Expected additional 2 day ICU stay * Ability to ambulate independently pre-hospital (with or without a gait aid)
Exclusion criteria
* Unable to follow simple commands at baseline * Pregnancy * Acute conditions impairing ability to walk or cycle (e.g., leg or foot fracture) * Acute central condition or peripheral injury resulting in neuromuscular weakness (e.g., stroke, Guillain Barré syndrome) * Primary generalized weakness of the central or peripheral nervous system (e.g., multiple sclerosis, myasthenia gravis, Parkinson's disease, amyotrophic lateral sclerosis) * Temporary pacemaker wires * Expected hospital mortality\> 90% * Cycling equipment unable to fit patient's body dimensions (e.g., leg amputation or obesity) * Specific surgical exclusion as stipulated by attending -\>7 day ICU stay * Physician declines * Patient did not meet daily screening criteria to provide in-bed leg cycling during the first 4 days of mechanical ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of in-bed leg cycling research sessions terminated (composite outcome) | From date of enrollment until date of ICU discharge, approximately 10 days on average | Research sessions will stop if the patient meets any of the following criteria: * Sustained oxygen desaturation \<88%, despite adjustments to FiO2 * Heart rate * Low: 20 bpm less than lowest baseline value or 40 bpm (whichever is highest) * High: 20 bpm more than highest baseline value or 140 bpm (whichever is lowest) * Mean Arterial Pressure \<55 or \>110 mmHg * Marked ventilator dyssynchrony not corrected by adjusting cycle off criteria Safety events: * Suspected new unstable / uncontrolled arrhythmia * Concern for myocardial ischaemia * Respiratory distress leading to symptoms of intolerable dyspnea * Unplanned extubation Any of the following catheter or tube dislodgements * Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter * Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy ICU physician, patient or proxy requests termination of session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling | From date of enrollment until date of ICU discharge, approximately 10 days on average | Any of the following catheter or tube dislodgements: * Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter * Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy |
| Daily research session delivery rate | From date of enrollment until date of ICU discharge, approximately 10 days on average | We will assess our ability to deliver cycling during the ICU stay by comparing our daily delivery rate with that achieved in ICU rehabilitation randomized clinical trials (80%). |
| Rate of outcome measure ascertainment in assessable patients at ICU awakening | 5 days after study admission, on average | We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates. |
| Rate of outcome measure ascertainment in assessable patients at ICU discharge | 10 days after study admission, on average | We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates. |
| Rate of outcome measure ascertainment in assessable patients at hospital discharge | 15 days after study admission, on average | We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates. |
| Consent rate feasibility | 1 year | Consent rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Leg and overall body strength at ICU awakening, ICU discharge, and hospital discharge | From study admission to approximately 5, 10, and 15 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). |
| Quadriceps Leg Strength - hand held dynamometer at ICU awakening, ICU discharge, and hospital discharge | From study admission to approximately 5, 10, and 15 days, on average, respectively | The patient exerts a force against a small strain gauge that fits in the examiner's hand. Force measured in Kg and in Newtons on a continuous scale. |
| Grip Strength - Hand grip dynamometer at ICU awakening, ICU discharge, and hospital discharge | From study admission to approximately 5, 10, and 15 days, on average, respectively | Force measured in Kg. Force measured in Kg and in Newtons on a continuous scale. |
| Functional Status Scale for ICU at ICU awakening ICU, ICU discharge, and hospital discharge | From study admission to approximately 5, 10, and 15 days, on average, respectively | The patient attempts 5 bed mobility/ transfer tasks: rolling, supine to sit, sitting at edge of be, transfer from sit to stand, ambulation. Each item assessed on a scale from 0 (unable to perform) to 7 (independent). |
| Katz Activities of Daily Living Scale at ICU awakening, ICU discharge, and hospital discharge | From study admission to approximately 5, 10, and 15 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. |
| Physical Function Test for ICU at ICU awakening, ICU discharge, and hospital discharge | ICU awakening, ICU discharge, From study admission to approximately 5, 10, and 15 days, on average, respectively | The patient completes 4 tasks: sit to stand, marching on the spot, repeated bilateral shoulder flexion, and muscle strength assessment (knee extension, shoulder flexion). |
| Patient-Specific Functional Scale at ICU awakening, ICU discharge, and hospital discharge | From study admission to approximately 5, 10, and 15 days, on average, respectively | The patient rates their ability to complete a specific task on a scale from 0 (unable to perform activity) to 10 (able to perform activity at baseline level). |
Countries
Canada
Outcome results
None listed