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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Peripheral Vascular Disease Vasoconstriction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Specialized pulse oximetry probe with external heat pack

Intervention Type OTHER

Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.

Standard of Care Pulse Oximetry Probe

Intervention Type OTHER

Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.

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.

Group Type ACTIVE_COMPARATOR

Specialized pulse oximetry probe with external heat pack

Intervention Type OTHER

Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.

Standard of Care Pulse Oximetry Probe

Intervention Type OTHER

Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.

Interventions

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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.

Intervention Type OTHER

Standard of Care Pulse Oximetry Probe

Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years
2. Able to give informed consent
3. Patients must be able to read and understand English.
4. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes