CardiO Cycle: A Pilot Safety and Feasibility Study of In-Bed Cycling in Patients Post Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Feasibility of completing 80% of eligible cycling sessions
研究概览
简要总结
The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit.
详细描述
Background: Advances in medical science and technologies have lead to more effective management of critically-ill patients with a subsequent improvement in ICU survival rates. Patients who survive their ICU stay are often left with post-ICU impairments including muscle weakness and functional limitations. Cardiac surgeries are commonly performed worldwide with the majority of patients requiring post-operative ICU care. In the past decade, patients who qualify for cardiac surgery tend to be older, have a great number of co-morbidities and are more likely to require a prolonged ICU stay. The effectiveness of physiotherapy and various rehabilitation modalities in patients both pre- and post cardiac surgery has been investigated. However, to date no study specifically addresses the feasibility and safety of in-bed cycling in patients undergoing cardiac surgery who require prolonged critical care.
Principle Research Question: Is in-bed cycling a safe and feasible intervention in patients post cardiac surgery that require a prolonged stay in critical care?
Methods: Adult patients post-cardiac surgery admitted to the cardiac surgery ICU who will remain intubated and ventilated for at least 72 hours will be eligible for enrollment. Participants will receive 20 minutes of in-bed cycling plus routine physiotherapy performed by critical care physiotherapists. Patients will be enrolled for 28 days or until they are able to ambulate.
Primary Outcomes: Safety of bedside cycling will be evaluated by monitoring the number of adverse events that occur during each cycling session. Feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least eighty percent of the time that cycling is appropriate.
Relevance: Before conducting a larger randomized controlled trial investigating the effectiveness of in-bed cycling in the critically-ill cardiac surgery population, the safety of this intervention needs to be determined. This will be the first study in a program of research evaluating bedside cycling in the cardiac surgical ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults patients aged 18 years and greater
- •History of cardiac surgery in the past seven days
- •Admitted to the cardiac surgery ICU for greater than 3 days but less than 7 days
- •Mechanically ventilated for at least 72 hours and expected to remain ventilated for at least two more days
- •Able to ambulate independently, with or without a gait aid, prior to hospital admission
排除标准
- •Uncomplicated post-operative course with expected discharge to ward within 24 to 72 hours
- •Previous lower extremity amputation
- •Open or unstable saphenous vein graft sites
- •Inability to understand English
- •Body size and/or weight that is incompatible with the bedside ergometer
- •Patients who are not expected to survive their ICU stay
结局指标
主要结局
Feasibility of completing 80% of eligible cycling sessions
时间窗: From date of study enrollment to the date of study completion, up to 28 days maximum
The feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least 80% of the time that cycling is appropriate.
Number of safety events that occur during cycling sessions
时间窗: From date of study enrollment until the date of study completion, up to 28 days maximum
Potential safety events include: * Hypertension (systolic blood pressure greater than 160 mmHg) * Hypotension (systolic blood pressure less than 90 mmHg) * Oxygen desaturation to less than 85% for more than two minutes * Cardiorespiratory arrest * Removal of any lines or tubes (chest tubes, pulmonary artery catheter, nasal-gastric tube, Jackson-Pratt drains, central venous catheter, endotracheal tube, tracheostomy decannulation) * New onset cardiac arrhythmias (atrial fibrillation, bigeminy, trigeminy, junctional, heart block rhythms) * Saphenous vein graft dehiscence * New onset agitation
次要结局
- Functional Status Score for the ICU (FSS-ICU)(Assessed daily, up to a maximum of 28 days)
- Feasibility of Completing Hand Grip Strength at ICU Awakening and ICU Discharge(When patient awake (unspecified time, patient dependent), at completion of study involvement (maximum: day 28 of ICU))
- Two Minute Walk Test(At ICU Awakening (an estimated 8 days after study enrollment) and at the completion of the study (maximum: day 28 of ICU))
研究者
Anastasia Newman
Physiotherapist, PhD Student
Hamilton Health Sciences Corporation