TIMMY3 80601-2-56:2017 + A1 2018 Clinical Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 10
- 主要终点
- Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias
研究概览
简要总结
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.
详细描述
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to 80601-2-56:2017 + A1 2018.
This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms. Testing will be performed with a production equivalent CVSM modified to use TIMMY3 (TIMMY3 investigational device), running the SureTemp Plus algorithms. The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as, but not limited to, the Connex Spot Monitor and Spot 4400. The process described below will be followed in accordance with the method called out in ISO 80601-2-56:2017 + A1:2018.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study:
- •Subjects that are minors must provide assent to the clinical site's policy (if approved by Baxter) and/or the study sponsor's policy to participate in the study.
- •Subject or the legally authorized representative (LAR) must sign the informed consent form in order for the subject to participate.
- •Subject must be willing and able to comply with the study procedures.
- •Age: normal weight (full-term) newborn to adult
- •The study subject is in ambient temperature for at least 20 minutes prior to participating.
- •The study subject is able to have their temperature taken for up to six minutes for multiple rounds of temperatures per anatomical site.
- •The study subject is not physically or emotionally agitated/uncooperative.
- •The study subject or legal guardian speaks/understands fluent English.
排除标准
- •Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced.
- •The study subject has anatomical abnormalities that would affect temperature.
- •The study subject has any known contraindication to oral, axillary, or rectal temperature measurements.
- •The subject is not alert or unable to follow simple commands such as closing one's mouth completely around the probe if an oral reference temperature is being taken.
- •The study subject has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
- •The study subject has engaged in strenuous or semi-strenuous activity within the last twenty minutes (i.e., running, weightlifting, etc.).
- •Subject has taken antipyretics (Aspirin, acetaminophen, ibuprofen) in the preceding 120 minutes.
- •Subjects has medical conditions such as inflammation at the MEASURING SITE (Barbiturates, thyroid preparations, antipsychotics, recent immunizations).
- •Neutropenic immunocompromised patients, in whom rectal manipulation may seed the blood with bacteria.
- •Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.
研究组 & 干预措施
Oral Temperature Measurement
Febrile and non-febrile subjects aged 5 years or older.
干预措施: Connex CVSM with Timmy3 module (Device)
Pediatric Axillary Temperature Measurement
Febrile and non-febrile pediatric subjects <1 year to <18 years.
干预措施: Connex CVSM with Timmy3 module (Device)
Adult Axillary Temperature Measurement
Febrile and non-febrile adult subjects >= 18 years old.
干预措施: Connex CVSM with Timmy3 module (Device)
Rectal Temperature Measurement
Febrile and non-febrile adult and pediatric subjects newborn and older.
干预措施: Connex CVSM with Timmy3 module (Device)
结局指标
主要结局
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias
时间窗: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias
时间窗: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias
时间窗: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias
时间窗: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias
时间窗: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias
时间窗: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias
时间窗: 20-30 minutes
Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement
时间窗: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement
时间窗: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement
时间窗: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement
时间窗: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement
时间窗: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement
时间窗: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement
时间窗: 20-30 minutes
Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability
时间窗: 20-30 minutes
Clinical repeatability is defined per ISO 80601-2-56:2017 + A1:2018 as the pooled within-subject standard deviation (SD) of triplicate device-under-test output temperatures for each anatomical site (refer to ISO formulas \[5\] and \[6\]). This outcome reports that SD as a single numeric value (°C); because it is a dispersion statistic (not a mean), no central-tendency measure applies. Higher SD indicates lower repeatability.
次要结局
未报告次要终点