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Radial Artery Vasodilation Heat Study

Radial Artery Vasodilation With Distal Topical Heat Study

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03620383
Enrollment
45
Registered
2018-08-08
Start date
2018-08-03
Completion date
2018-09-18
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radial Artery

Keywords

Transradial access, Radial artery, Vasodilation, Heat

Brief summary

The purpose of this study is to collect data about the efficacy of utilizing distal topical heat application for dilatation of the radial artery. Transradial arterial access is widely accepted as the standard of care for cardiac catheterization procedures due to its increased patient comfort and significantly decreased risk of major vascular complications, and has been recently utilized in increasing volume by the interventional radiology community throughout the world. Due to the small size of the radial artery, catheterization may sometimes be technically difficult. Pre-procedure dilatation can make catheterization significantly easier, and studies have demonstrated the successful ability to dilate the radial artery with the use of topical nitroglycerin and lidocaine. However, the investigators hypothesize that utilizing topical heat applied distally can create a physiologic vasodilatation similar to that created with nitroglycerin and lidocaine, but at a significantly lower cost and with less risk due to no need for application of a medication which has a systemic effect with known side effects. The purpose of this study is to test the efficacy of radial artery vasodilatation with distal topical heat application.

Detailed description

The study will be designed to detect a significant increase in the radial artery diameter of healthy volunteers after the application of a warm heat pack in the palmar aspect of the hand compared to a control group without heat applied to the hand. Employees and students at OHSU will be considered for enrollment as volunteers for this minimal risk study. Informed consent will be obtained from healthy volunteers prior to enrollment. After enrollment, the healthy volunteers will be randomly assigned in a 2:1 ratio to the heat group (Group 1) or the control group (Group 2), respectively. A brief medical history will be obtained from all volunteers, including age, sex, medications, prior interventions, prior surgeries, previous medical diagnoses, allergies, and any history of prior transradial procedures. For protection of confidential health information, brief medical history will be obtained in a private area. The volunteers will then be seated and the left hand placed supinated in a comfortable position on a table. A limited ultrasound of the left radial artery will be performed using grayscale ultrasound. A skin mark will be made with a marker to identify the measurement site. All volunteers will then be given a commercially available warm heat pack and asked to hold gently in their left hand. For the control group (Group 2), the warm heat pack will not be activated. For the heat group (Group 1), the warm heat back will be activated prior to placing in the volunteer's hand. Two investigators will be present. One investigator will be measuring radial artery diameter and will not be aware if the heat pack is activated. The second investigator will be aware of the volunteer's randomly assigned group and will activate the heat pack for the volunteer if they are assigned to Group 1. Over a period of 20 minutes, repeat ultrasound of the left radial artery will be performed in 5 minute intervals.

Interventions

PROCEDURETopical Heat

Warm heat pack applied topically in participant hand.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Volunteers who are 18-99 years old

Exclusion criteria

* Prior left transradial access for procedure

Design outcomes

Primary

MeasureTime frameDescription
Radial Artery Cross Sectional Area20 minutes after application of topical heatRadial artery cross sectional area after 20 minutes with or without heat application

Countries

United States

Participant flow

Participants by arm

ArmCount
Heat
Distal topical heat application Topical Heat: Warm heat pack applied topically in participant hand.
30
No Heat
Inactive heat pack to blind the investigator.
15
Total45

Baseline characteristics

CharacteristicHeatNo HeatTotal
Age, Continuous37.7 years
STANDARD_DEVIATION 10.4
34.2 years
STANDARD_DEVIATION 9.3
36.5 years
STANDARD_DEVIATION 10.1
Baseline radial artery cross sectional area2.5 mm^2
STANDARD_DEVIATION 0.8
3.2 mm^2
STANDARD_DEVIATION 1.1
2.7 mm^2
STANDARD_DEVIATION 1
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
23 Participants5 Participants28 Participants
Sex: Female, Male
Male
7 Participants10 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 15
other
Total, other adverse events
0 / 300 / 15
serious
Total, serious adverse events
0 / 300 / 15

Outcome results

Primary

Radial Artery Cross Sectional Area

Radial artery cross sectional area after 20 minutes with or without heat application

Time frame: 20 minutes after application of topical heat

ArmMeasureValue (MEAN)Dispersion
HeatRadial Artery Cross Sectional Area3.4 mm^2Standard Deviation 1.3
No HeatRadial Artery Cross Sectional Area3.0 mm^2Standard Deviation 1.2

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026