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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by VA Pittsburgh Healthcare System
Sponsor:
Collaborator:
Medline Industries
Information provided by (Responsible Party):
Cathy Abee, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier:
NCT01992939
First received: November 13, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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 Intervention
Healthy
Peripheral Vascular Disease
Vasoconstriction
Other: Specialized pulse oximetry probe with external heat pack
Other: Standard of Care Pulse Oximetry Probe

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Heat on Blood and Oxygen Flow Readings Part 2

Resource links provided by NLM:


Further study details as provided by VA Pittsburgh Healthcare System:

Primary Outcome Measures:
  • Pulse Oximetry [ Time Frame: measured at least every 5 minutes - day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial Blood Gas [ Time Frame: measured once - day 1 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Temperature [ Time Frame: measured at least every 5 minutes - day 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992939

Contacts
Contact: Catherine Abee, CRT 412-360-3878 catherine.abee@va.gov

Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Cathy Abee    412-360-3878      
Principal Investigator: Cathy Abee         
Sponsors and Collaborators
VA Pittsburgh Healthcare System
Medline Industries
Investigators
Principal Investigator: Catherine Abee, CRT VA Pittsburgh Healthcare System
  More Information

No publications provided

Responsible Party: Cathy Abee, Medical Instrument Technologist, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT01992939     History of Changes
Other Study ID Numbers: PulsOx-002
Study First Received: November 13, 2013
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Pittsburgh Healthcare System:
pulse
heat
blood circulation

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014