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

Abstract

Introduction: 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.

Methods: 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).

Results: 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%]).

Conclusions: 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.

Trial registration: Clinicaltrials.gov: NCT01885442.

Conflict of interest statement

Michelle Kho received an equipment loan of 2 RT300 supine cycles from Restorative Therapies, Baltimore, MD for a different 7-centre multi-center pilot randomized trial of in-bed cycling that is distinct from this work. Margaret Herridge is a site co-investigator at one of the centers where Dr. Kho received the equipment loan from Restorative Therapies for this new study. This does not alter our adherence to PLOS ONE policies on sharing data and materials. On behalf of the remaining authors, the corresponding author states there is no conflict of interest.

Figures

Fig 1. Example of in-bed cycling.

This figure demonstrates a patient in the ICU receiving in-bed cycling and mechanical ventilation. An ICU physiotherapist supervises the in-bed cycling session.

Fig 2. Patient flow diagram.

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 110 mmHg (n = 1), heart rate 140 beats per minute (n = 1), other concern (n = 8).

Fig 3. Histogram of cycling by day of ICU stay.

This figure outlines the number of patients biking by days since ICU admission. Of 205 in bed cycling sessions, over half (106 (52%)) occurred within the first 7 days of the patient’s ICU admission.