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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992939
• Other study ID #: PulsOx-002
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: February 1, 2016
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: VA Pittsburgh Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases
• Vasoconstriction

Intervention

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

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
VA Pittsburgh Healthcare System	Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Temperature		measured at least every 5 minutes - day 1	Yes
Primary	Pulse Oximetry		measured at least every 5 minutes - day 1	No
Secondary	Arterial Blood Gas		measured once - day 1	No