TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients

<div><p>Introduction</p><p>The objective of this study was to assess the safety and feasibility of in-bed cycling started within the first 4 days of mechanical ventilation (MV) to inform a future randomized clinical trial.</p><p>Methods</p><p>We conducted a 33-patient prospective cohort study in a 21-bed adult academic medical-surgical intensive care unit (ICU) in Hamilton, ON, Canada. We included adult patients (≥ 18 years) receiving MV who walked independently pre-ICU. Our intervention was 30 minutes of in-bed supine cycling 6 days/week in the ICU. Our primary outcome was Safety (termination), measured as events prompting cycling termination; secondary Safety (disconnection or dislodgement) outcomes included catheter/tube dislodgements. Feasibility was measured as consent rate and fidelity to intervention. For our primary outcome, we calculated the binary proportion and 95% confidence interval (CI).</p><p>Results</p><p>From 10/2013-8/2014, we obtained consent from 34 of 37 patients approached (91.9%), 33 of whom received in-bed cycling. Of those who cycled, 16(48.4%) were female, the mean (SD) age was 65.8(12.2) years, and APACHE II score was 24.3(6.7); 29(87.9%) had medical admitting diagnoses. Cycling termination was infrequent (2.0%, 95% CI: 0.8%-4.9%) and no device dislodgements occurred. Cycling began a median [IQR] of 3 [2, 4] days after ICU admission; patients received 5 [3, 8] cycling sessions with a median duration of 30.7 [21.6, 30.8] minutes per session. During 205 total cycling sessions, patients were receiving invasive MV (150 [73.1%]), vasopressors (6 [2.9%]), sedative or analgesic infusions (77 [37.6%]) and dialysis (4 [2.0%]).</p><p>Conclusions</p><p>Early cycling within the first 4 days of MV among hemodynamically stable patients is safe and feasible. Research to evaluate the effect of early cycling on patient function is warranted.</p><p>Trial Registration</p><p>Clinicaltrials.gov: <a href="https://clinicaltrials.gov/ct2/show/NCT01885442" target="_blank">NCT01885442</a></p></div

Characteristics of <i>a-priori</i> physiologic changes from baseline during in-bed cycling sessions.

<p>Characteristics of <i>a-priori</i> physiologic changes from baseline during in-bed cycling sessions.</p

Study Inclusion, Exclusion, and Temporary exemption criteria.

<p>Study Inclusion, Exclusion, and Temporary exemption criteria.</p

Patient strength and functional outcomes.

<p>Patient strength and functional outcomes.</p

Patient flow diagram.

<p>This figure outlines patient screening and enrollment in the TryCYCLE study. The 68 persisting temporary exemptions within the first 4 days of mechanical ventilation included: receipt of neuromuscular blocking agents (n = 19), increase in vasoactive infusions (n = 14), femoral arterial or venous catheter in situ (n = 13), active myocardial infarction of unstable/ uncontrolled arrhythmia (n = 8), severe agitation (n = 2), persistent SpO2 <88% (n = 2), mean arterial pressure <60 mmHg or >110 mmHg (n = 1), heart rate <40 or >140 beats per minute (n = 1), other concern (n = 8).</p