The Effect of Heat on Blood and Oxygen Flow Readings Part 2

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
150 patients will be approached in order to ensure 110 patients will be enrolled in this study total. 30 patients will have peripheral vascular disease (PVD), vasoconstriction, or hypothermic extremities and 80 patients with no blood flow issues will be enrolled. The patients will serve as their own controls. Each patient will have a specialized pulse oximetry probe with external heat pack added to their extremity while measuring pulse oximetry. These SaO2 readings will be compared to SaO2 readings obtained from an arterial blood gas obtained during the course of the study.

Official Title
-----------------
The Effect of Heat on Blood and Oxygen Flow Readings Part 2

Conditions
-----------------
Healthy, Peripheral Vascular Disease, Vasoconstriction

Intervention / Treatment
-----------------
* Other: Specialized pulse oximetry probe with external heat pack
* Other: Standard of Care Pulse Oximetry Probe


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-Healthy Subjects arm<br>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 | Other: Specialized pulse oximetry probe with external heat pack<br>* Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.<br>Other: Standard of Care Pulse Oximetry Probe<br>* Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.<br>|
| Active Comparator: Healthy Subjects Arm<br>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. | Other: Specialized pulse oximetry probe with external heat pack<br>* Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.<br>Other: Standard of Care Pulse Oximetry Probe<br>* Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Oximetry |  | measured at least every 5 minutes - day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood Gas |  | measured once - day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulse, heat, blood circulation