TY - JOUR T1 - Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients JF - BMJ Open Respiratory Research JO - BMJ Open Resp Res DO - 10.1136/bmjresp-2018-000383 VL - 6 IS - 1 SP - e000383 AU - Michelle E Kho AU - Alexander J Molloy AU - France J Clarke AU - Julie C Reid AU - Margaret S Herridge AU - Timothy Karachi AU - Bram Rochwerg AU - Alison E Fox-Robichaud AU - Andrew JE Seely AU - Sunita Mathur AU - Vincent Lo AU - Karen EA Burns AU - Ian M Ball AU - Joseph R Pellizzari AU - Jean-Eric Tarride AU - Jill C Rudkowski AU - Karen Koo AU - Diane Heels-Ansdell AU - Deborah J Cook A2 - , Y1 - 2019/02/01 UR - http://bmjopenrespres.bmj.com/content/6/1/e000383.abstract N2 - Introduction Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient’s ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients.Methods We conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1–2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge).Results Between 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded.Discussion Our pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible.Trial registration number NCT02377830. ER -