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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
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).
St. Joseph's Healthcare Intensive Care Unit
Hamilton, Ontario, Canada
Number of in-bed leg cycling research sessions terminated (composite outcome)
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
Time frame: From date of enrollment until date of ICU discharge, approximately 10 days on average
Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling
Any of the following catheter or tube dislodgements: * Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter * Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy
Time frame: From date of enrollment until date of ICU discharge, approximately 10 days on average
Daily research session delivery rate
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%).
Time frame: From date of enrollment until date of ICU discharge, approximately 10 days on average
Rate of outcome measure ascertainment in assessable patients at ICU awakening
We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
Time frame: 5 days after study admission, on average
Rate of outcome measure ascertainment in assessable patients at ICU discharge
We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
Time frame: 10 days after study admission, on average
Rate of outcome measure ascertainment in assessable patients at hospital discharge
We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
Time frame: 15 days after study admission, on average
Consent rate feasibility
Consent rate
Time frame: 1 year
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