Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Kho Michelle E, Reid Julie, Molloy Alexander J, Herridge Margaret S, Seely Andrew J, Rudkowski Jill C, Buckingham Lisa, Heels-Ansdell Diane, Karachi Tim, Fox-Robichaud Alison, Ball Ian M, Burns Karen E A, Pellizzari Joseph R, Farley Christopher, Berney Sue, Pastva Amy M, Rochwerg Bram, D'Aragon Frédérick, Lamontagne Francois, Duan Erick H, Tsang Jennifer L Y, Archambault Patrick, English Shane W, Muscedere John, Serri Karim, Tarride Jean-Eric, Mehta Sangeeta, Verceles Avelino C, Reeve Brenda, O'Grady Heather, Kelly Laurel, Strong Geoff, Hurd Abby H, Thabane Lehana, Cook Deborah J, CYCLE Investigators and the Canadian Critical Care Trials Group
Аннотация
METHODS AND ANALYSIS: We report a parallel group RCT of 360 patients in 17 medical-surgical ICUs and three countries. We include adults (≥18 years old), who could ambulate independently before their critical illness (with or without a gait aid), ≤4 days of invasive mechanical ventilation and ≤7 days ICU length of stay, and an expected additional 2-day ICU stay, and who do not fulfil any of the exclusion criteria. After obtaining informed consent, patients are randomised using a web-based, centralised system to either 30 min of in-bed cycling in addition to routine PT, 5 days per week, up to 28 days maximum, or routine PT alone. The primary outcome is the Physical Function ICU Test-scored (PFIT-s) at 3 days post-ICU discharge measured by assessors blinded to treatment allocation. Participants, ICU clinicians and research coordinators are not blinded to group assignment. Our sample size estimate was based on the identification of a 1-point mean difference in PFIT-s between groups.
ETHICS AND DISSEMINATION: Critical Care Cycling to improve Lower Extremity (CYCLE) is approved by the Research Ethics Boards of all participating centres and Clinical Trials Ontario (Project 1345). We will disseminate trial results through publications and conference presentations.
TRIAL REGISTRATION NUMBER: NCT03471247 (Full RCT); NCT02377830 (CYCLE Vanguard 46 patient internal pilot).