Early Rehabilitation in Critically Ill Children Pilot Study (WeeHab in PCCU)
Early Rehabilitation in Critically Ill Children, a Pilot Study
研究概览
详细说明
In this prospective cohort pilot study, eligible critically ill children aged 3 to 17 years will receive in addition to their usual care, a passive and/or an active mobility intervention, depending on their level of consciousness or cognitive ability. The active intervention will consist of an interactive video game (X Box 360 Kinect), while a cycle ergometer will be used as the passive intervention. The mobility interventions will be applied for a minimum of 10 minutes on day 1, and 20 minutes on day 2. For unconscious patients, or eligible patients who cognitively impaired, the passive intervention will be applied. As soon as the patient is conscious and cooperative, the active intervention will be applied.
The primary outcomes of interest in this pilot study are feasibility (defined as the ability to screen and enroll patients, consent rate and protocol adherence). Secondary outcomes of interest include safety outcomes, clinical outcomes and patient and caregiver satisfaction with the intervention.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Ontario
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Hamilton、Ontario、加拿大、L8N 3Z5
- McMaster Children's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Anticipated PCCU stay of more than 24 hours.
- Clinical stable children at PCCU
- Informed consent and or assent where appropriate
- Agreement of the most responsible PCCU physician
- Age ≥ 3years to < 18 years
Exclusion Criteria:
- Hemodynamic instability, defined as requiring escalation in vasoactive agents or volume resuscitation within the preceding 4 hours. (Patients who are on stable or weaning doses of vasoactive agents will be considered eligible).
- Anticipated death and/ or withholding of life-sustaining therapies
- The presence of a contraindication to mobilization- e.g. Suspected or actual evidence of cerebral edema or elevated ICP, unstable spinal cord injuries, musculoskeletal injuries/ fixed deformities in the lower limbs (for the use of cycle ergometer) or the upper limbs (for the use of interactive video-gaming)
- Unstable airway (defined as impending respiratory failure and/or endotracheal intubation is anticipated within the next 4 hours).
- Patients who are already mobilizing well/or at their baseline level of function
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Single Arm: Study Intervention
Cycle ergometry and/or Interactive video-game
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其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility
大体时间:2 days
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The primary outcome of interest in this pilot study is feasibility. Feasibility is defined as follows:
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2 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety
大体时间:Study period
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The proportion of patients with adverse events attributable to the rehabilitation intervention (e.g.
cardiorespiratory events, tube dislodgement's).
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Study period
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Change in activity from baseline
大体时间:From baseline to end of intervention
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Change in activity from baseline, during and following the intervention as measured by accelerometer, and patient
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From baseline to end of intervention
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Caregiver/user perception of intervention
大体时间:At end of study period
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Self-administered survey of caregiver and or user, to evaluate perceptions of intervention
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At end of study period
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合作者和调查者
调查人员
- 首席研究员:Karen Choong, MB, BCh, MSc、McMaster University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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