Ignite Creation Date:
2024-05-06 @ 2:14 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01992939
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2013-11-13
Brief Title:
The Effect of Heat on Blood and Oxygen Flow Readings Part 2
Sponsor:
VA Pittsburgh Healthcare System
Organization:
VA Pittsburgh Healthcare System
Study Overview
Official Title:
The Effect of Heat on Blood and Oxygen Flow Readings Part 2
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None