The Effect of Heat on Blood and Oxygen Flow Readings Part 2
This is the second part of a research study in order to determine if using a specialized pulse oximetry probe with external heat pack will help obtain oxygen saturation (SaO2) and heart rate (HR) during monitoring for patients with peripheral vascular disease (PVD), vasoconstriction, and hypothermic extremities. The inability to obtain accurate SaO2 and pulse readings can lead to misdiagnosis, incorrect treatment, or procedures to be canceled. SaO2 and pulse readings are important to maintain patient stability during diagnostic testing, surgical procedures and monitoring while in critical care areas. Changes in SaO2 and pulse are important to monitor in order to be able to compensate for any decrease in patient oxygen saturations during hemodynamic monitoring.
The primary aim of this study is to determine if using a specialized pulse oximetry probe with external heat pack will improve oxygenation readings in order to obtain SaO2 and pulse readings in patients with PVD, vasoconstriction, and hypothermic extremities as compared to readings obtained from an arterial blood gas.
The hypothesis is using a specialized pulse oximetry probe with external heat pack will help obtain more accurate pulse oximetry readings consistent with values obtained with an arterial blood gas.
研究概览
地位
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15240
- VA Pittsburgh Healthcare System
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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:
- Age > 18 years
- Able to give informed consent
- Patients must be able to read and understand English.
- Patients scheduled to enter the VA Pittsburgh Healthcare System catheterization lab
Arm 2 of the study:
1. The PI will determine if patients have poor circulation due to obstruction of the large arteries in their arms and legs (peripheral vascular disease (PVD), narrowing of their blood vessels (vasoconstriction), or extremities (arms, legs, etc) that are at least 3 degrees Fahrenheit below their normal body temperature. If patients do have any of the following they will be considered for arm 2. If they do not they will be considered for arm 1.
Exclusion Criteria:
In addition to the exclusions mentioned above, patients with the following conditions will be excluded from the trial:
1. Inability or unwillingness to sign informed consent with free will and sound mind, as determined by a score of <11 on the Evaluation to Sign Consent Form.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 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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有源比较器：Non-Healthy Subjects arm
Subjects in this arm will have peripheral vascular disease (PVD), vasoconstriction, or hypothermic extremities and they will receive two pulse oximetry probes.
One probe will be a standard of care pulse oximetry probe and the second probe is the specialized pulse oximetry probe with external heat pack
|
Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
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有源比较器：Healthy Subjects Arm
Subjects who do not have peripheral vascular disease (PVD), vasoconstriction, or hypothermic extremities will be considered healthy subjects and they will receive two pulse oximetry probes.
One probe will be a standard of care pulse oximetry probe and the second probe is the specialized pulse oximetry probe with external heat pack.
|
Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Pulse Oximetry
大体时间：measured at least every 5 minutes - day 1
|
measured at least every 5 minutes - day 1
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Arterial Blood Gas
大体时间：measured once - day 1
|
measured once - day 1
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Temperature
大体时间：measured at least every 5 minutes - day 1
|
measured at least every 5 minutes - day 1
|
合作者和调查者
调查人员
- 首席研究员：Catherine Abee, CRT、VA Pittsburgh Healthcare System
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.