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

Primary Purpose

Healthy, Peripheral Vascular Disease, Vasoconstriction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specialized pulse oximetry probe with external heat pack
Standard of Care Pulse Oximetry Probe
Sponsored by
VA Pittsburgh Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring pulse, heat, blood circulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • VA Pittsburgh Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Non-Healthy Subjects arm

Healthy Subjects Arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pulse Oximetry

Secondary Outcome Measures

Arterial Blood Gas

Full Information

First Posted
November 13, 2013
Last Updated
February 1, 2016
Sponsor
VA Pittsburgh Healthcare System
Collaborators
Medline Industries
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1. Study Identification

Unique Protocol Identification Number
NCT01992939
Brief Title
The Effect of Heat on Blood and Oxygen Flow Readings Part 2
Official Title
The Effect of Heat on Blood and Oxygen Flow Readings Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Pittsburgh Healthcare System
Collaborators
Medline Industries

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Peripheral Vascular Disease, Vasoconstriction
Keywords
pulse, heat, blood circulation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Healthy Subjects arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Healthy Subjects Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Specialized pulse oximetry probe with external heat pack
Intervention Description
Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.
Intervention Type
Other
Intervention Name(s)
Standard of Care Pulse Oximetry Probe
Intervention Description
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
Primary Outcome Measure Information:
Title
Pulse Oximetry
Time Frame
measured at least every 5 minutes - day 1
Secondary Outcome Measure Information:
Title
Arterial Blood Gas
Time Frame
measured once - day 1
Other Pre-specified Outcome Measures:
Title
Temperature
Time Frame
measured at least every 5 minutes - day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Abee, CRT
Organizational Affiliation
VA Pittsburgh Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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