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

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ClinicalTrials.gov Identifier: NCT01992939
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : February 2, 2016
Sponsor:
Collaborator:
Medline Industries
Information provided by (Responsible Party):
Cathy Abee, VA Pittsburgh Healthcare System

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Peripheral Vascular Disease Vasoconstriction Other: Specialized pulse oximetry probe with external heat pack Other: Standard of Care Pulse Oximetry Probe Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of Heat on Blood and Oxygen Flow Readings Part 2
Study Start Date : November 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Other: 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.

Other: Standard of Care Pulse Oximetry Probe
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
Active Comparator: 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.
 Other: 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.

Other: Standard of Care Pulse Oximetry Probe
Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.


Outcome Measures
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Primary Outcome Measures :
  1. Pulse Oximetry [ Time Frame: measured at least every 5 minutes - day 1 ]

Secondary Outcome Measures :
  1. Arterial Blood Gas [ Time Frame: measured once - day 1 ]

Other Outcome Measures:
  1. Temperature [ Time Frame: measured at least every 5 minutes - day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992939


Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Pittsburgh Healthcare System
Medline Industries
Investigators
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Principal Investigator: Catherine Abee, CRT VA Pittsburgh Healthcare System
More Information
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Responsible Party: Cathy Abee, Medical Instrument Technologist, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT01992939    
Other Study ID Numbers: PulsOx-002
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Keywords provided by Cathy Abee, VA Pittsburgh Healthcare System:
pulse
heat
blood circulation
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases