NCT02005692已完成不适用
A Pilot Study to Assess the DynaSense System
Leaf Healthcare, Inc.1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Safety Primary Endpoint
研究概览
简要总结
The study is designed to test the DynaSense system, which is a patient movement and orientation monitoring system. The study is intended to determine that:
- the DynaSense system identifies patients that are not turning adequately on their own and therefore require caregiver-assisted turns.
- the DynaSense system identifies patients that are turning adequately on their own and therefore do not require a caregiver-assisted turn.
- the DynaSense system helps ensure compliance with an institution's established patient turning protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
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 male or female 18 to 110 years of age;
- •Inpatient currently on the unit and expected to remain for at least 12 hours;
- •Able and willing to comply with the study procedures;
- •Subject (or his/her agent) is able to read, understand, and provide Informed Consent in the English language.
排除标准
- •Subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding.
- •Any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; OR
- •Be postmenopausal for at least 2 years, OR
- •have had a bilateral tubal ligations, OR
- •have had a bilateral oophorectomy, OR
- •have had a hysterectomy.
- •Subjects with a known tape allergy or sensitivity to EKG leads or similar types of adhesives used in common medical products.
- •Subjects who cannot have the patient sensor applied on the surface of the patient's anterior torso.
- •Subjects who have a pacemaker or implantable cardiovascular-defibrillator (ICD).
- •Subjects with dementia, Alzheimer's disease or other mental disabilities and incapacitation that would prevent the subject from providing written informed consent. If the subject is unable to provide informed consent due to mental incapacity, then the subject's Durable Power of Attorney may provide informed consent and sign the informed consent on behalf of the subject.
- •Subjects who refuse to have an area of hair on their chest be clipped or shaved, if needed for patient sensor adhesion.
- •Subjects, who in the opinion of the Principal Investigator, are at increased risk by participating in the clinical study.
- •Subjects who have participated in another clinical study within the past 30 days or are currently participating in another clinical study at the time of screening.
研究组 & 干预措施
DynaSense sensor
Experimental
干预措施: DynaSense sensor (Device)
结局指标
主要结局
Safety Primary Endpoint
时间窗: Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.
The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.
Turn Protocol Compliance
时间窗: Subjects will be followed for the length of hospital stay which is expected to average 5 days.
The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.
次要结局
未报告次要终点
研究者
研究点 (1)
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