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

PLoS One. 2016 Dec 28;11(12):e0167561. doi: 10.1371/journal.pone.0167561. eCollection 2016.

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.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • Equipment Failure
  • Exercise*
  • Feasibility Studies
  • Female
  • Humans
  • Intensive Care Units
  • Male
  • Prospective Studies
  • Respiration, Artificial* / instrumentation
  • Safety*

Associated data

  • ClinicalTrials.gov/NCT01885442

Grants and funding

This work was supported by: Canadian Institutes of Health Research (www.cihr-irsc.gc.ca), Institute of Musculoskeletal Health and Arthritis Operating grant – Priority Announcement: IMHA New investigators - Bridge Funding (131584) MEK DJC MSH KK MM JR AS; Canada Research Chairs MEK DJC. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.