TryCYCLE (Critical Care Cycling to Improve Lower Extremity Strength): A Prospective Pilot Study of the Safety and Feasibility of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of in-bed leg cycling research sessions terminated (composite outcome)
研究概览
简要总结
Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very vulnerable to weakness and disability. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling employs special equipment that attaches to a patient's hospital bed, allowing them gentle leg exercise while in the ICU. The investigators will offer patients in-bed cycling while they are needing a breathing machine, to help them recover from weakness as fast as possible. Before doing a larger trial testing if in-bed cycling reduces disability, data on safety (Is it safe?) and feasibility (Can the investigators do it?) are needed.
Objectives: To study the safety and feasibility of in-bed leg cycling in critically ill patients who need breathing machines.
Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Specially trained physiotherapists will provide patients with 30 minutes of in-bed cycling each day while they are in the ICU.
Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of patients doing in-bed cycling, while carefully monitoring for safety. (2) Feasibility: whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether the investigators can assess patients' strength in the ICU and at hospital discharge.
Relevance: As the Canadian population ages, the demand for breathing machines during acute illness will increase dramatically. Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot study is the first of several future larger studies about in-bed cycling in the ICU. This program of research will help patients needing life support to regain their strength and recover as fast as possible from critical illness.
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
- •Adult patients ≥18 years old
- •Invasively mechanically ventilated ≤4 days
- •Expected additional 2 day ICU stay
- •Ability to ambulate independently pre-hospital (with or without a gait aid)
排除标准
- •Unable to follow simple commands at baseline
- •Pregnancy
- •Acute conditions impairing ability to walk or cycle (e.g., leg or foot fracture)
- •Acute central condition or peripheral injury resulting in neuromuscular weakness (e.g., stroke, Guillain Barré syndrome)
- •Primary generalized weakness of the central or peripheral nervous system (e.g., multiple sclerosis, myasthenia gravis, Parkinson's disease, amyotrophic lateral sclerosis)
- •Temporary pacemaker wires
- •Expected hospital mortality> 90%
- •Cycling equipment unable to fit patient's body dimensions (e.g., leg amputation or obesity)
- •Specific surgical exclusion as stipulated by attending
- •>7 day ICU stay
- •Physician declines
- •Patient did not meet daily screening criteria to provide in-bed leg cycling during the first 4 days of mechanical ventilation
结局指标
主要结局
Number of in-bed leg cycling research sessions terminated (composite outcome)
时间窗: From date of enrollment until date of ICU discharge, approximately 10 days on average
Research sessions will stop if the patient meets any of the following criteria: * Sustained oxygen desaturation \<88%, despite adjustments to FiO2 * Heart rate * Low: 20 bpm less than lowest baseline value or 40 bpm (whichever is highest) * High: 20 bpm more than highest baseline value or 140 bpm (whichever is lowest) * Mean Arterial Pressure \<55 or \>110 mmHg * Marked ventilator dyssynchrony not corrected by adjusting cycle off criteria Safety events: * Suspected new unstable / uncontrolled arrhythmia * Concern for myocardial ischaemia * Respiratory distress leading to symptoms of intolerable dyspnea * Unplanned extubation Any of the following catheter or tube dislodgements * Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter * Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy ICU physician, patient or proxy requests termination of session
次要结局
- Rate of outcome measure ascertainment in assessable patients at ICU discharge(10 days after study admission, on average)
- Daily research session delivery rate(From date of enrollment until date of ICU discharge, approximately 10 days on average)
- Rate of outcome measure ascertainment in assessable patients at hospital discharge(15 days after study admission, on average)
- Rate of outcome measure ascertainment in assessable patients at ICU awakening(5 days after study admission, on average)
- Consent rate feasibility(1 year)
- Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling(From date of enrollment until date of ICU discharge, approximately 10 days on average)