Remote Investigation and Assessment of Vital Signs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 860
- 试验地点
- 1
- 主要终点
- Agreement between conventional techniques and the new RIA-VS device
研究概览
简要总结
The vital signs (pulse, systolic and diastolic blood pressure, respiratory rate, oxygen saturation and body temperature) are critical in assessing the severity and prognosis of infections. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). Accurately obtaining vital signs is also important when managing other categories of patients where it may be relevant to obtain some of the vital signs such as pulse and blood pressure.
This project aims to evaluate a new camera-based system for contactless measurement of vital signs.
详细描述
STUDY DESIGN:
A method comparison design with three work packages (WP):
WP1: Focus on estimating validity and reliability of the new study device to measure body temperature.
WP2: Focus on estimating validity and reliability of the new study device to measure all vital signs except body temperature (pulse, systolic and diastolic blood pressure, respiratory rate and oxygen saturation).
WP3: Focus on estimating if there is any difference in the validity and reliability of the new study device to measure all vital signs (except body temperature) in subjects with Fitzpatrick skin type 5-6 as compared with those of skin type 1-4.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •The same subject can't be enrolled more than once with the exception that subjects in WP1 may also be recruited to WP
- •The patient is attending primary or secondary health care.
- •The subject has provided informed consent.
- •Age ≥18 years.
- •Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
- •The patient is willing and able to give informed consent ".
- •The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
- •The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.
- •Patients attending primary health care.
- •The subject has provided informed consent.
- •Age ≥18 years.
- •Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
- •The patient is willing and able to give informed consent .
- •The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
- •The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.
排除标准
- •Subjects are free to withdraw from the study at any point. Subjects will also be withdrawn from the study in case of unexpected depressed level of consciousness from inclusion up until all investigations are completed (during approximately 15-20 minutes). Any reduction in consciousness will incur that the subject is withdrawn.
结局指标
主要结局
Agreement between conventional techniques and the new RIA-VS device
时间窗: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Estimate the agreement between vital signs estimated with the new RIA-VS study device and vital signs estimated using traditional techniques (the criterion validity). Vital signs in this context are heart rate (pulse), respiratory rate, oxygen saturation (SpO2), systolic as well as diastolic blood pressure, and body temperature. For each vital sign the following statistics will be calculated to answer the outcome measure: a) Validity of the new method: The gold standard will be the mean between the two reference methods. The first measurement of the new RIA-VS device will be the new method compared with the gold standard using a Bland-Altman plot. We will also produce simple scatter plots comparing the gold standard with the new RIA-VS device for illustration.
次要结局
- Estimate test-retest reliability of the new RIA-VS device(The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes)
- Evaluate the influence of different skin types on the validity of the new RIA-VS study device(The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes)