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Completed

NCT Number: NCT01992939

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.

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Key information

Conditions

Healthy Cardiovascular Diseases Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Diseases Vasoconstriction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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:

  • 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.

Treatment and study plan

Specialized pulse oximetry probe with external heat pack

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

Other

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

Primary outcomes

  1. Pulse Oximetry

    Time frame: measured at least every 5 minutes - day 1

Secondary outcomes

  1. Arterial Blood Gas

    Time frame: measured once - day 1

Other outcomes

  1. Temperature

    Time frame: measured at least every 5 minutes - day 1

Sponsors and collaborators

Lead sponsor

VA Pittsburgh Healthcare System

Fed

Collaborators

  • Medline Industries

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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