Journal Article

Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients

Karachi, Timothy, Fox-Robichaud, Alison E, Pellizzari, Joseph R, Koo, Karen, Rudkowski, Jill C, Lo, Vincent, Burns, Karen EA, Rochwerg, Bram, Seely, Andrew JE, Mathur, Sunita, Clarke, France J, Molloy, Alexander J, Herridge, Margaret S, Tarride, Jean-Eric, Cook, Deborah J, Reid, Julie C, Ball, Ian M, Heels-Ansdell, Diane, Kho, Michelle E

2019

Overview

IntroductionAcute 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.MethodsWe 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).ResultsBetween 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.DiscussionOur 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.

• Publisher: British Thoracic Society,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Aged / Aged, 80 and over / Anesthesia / bed rest/ adverse effects / Clinical trials / Comorbidity / Consent / Critical Care / Critical Illness - rehabilitation / Early Medical Intervention / Ergometry / Evidence-based medicine / Exercise / exercise therapy / Exercise Therapy - methods / Feasibility Studies / Female / Hospitals / Humans / Illnesses / Intensive care / Intervention / Male / Middle Aged / Patients / Physical therapy / Pilot Projects / Point-of-Care Systems / Rehabilitation / Respiration, Artificial / respiration, artificial/adverseeffects/ methods / Sepsis / Single-Blind Method / Systematic review