Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-04-30

Brief Summary

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The purpose of this single-blind, randomized control trial will be to investigate whether simply having warmed gel, as compared to room-temperature gel, during a bedside ultrasound significantly improves patient satisfaction scores.

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Detailed Description

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ED physicians who identify that a patient will require an ultrasound will page the ultrasound team as part of standard of care. At that time, an investigator will obtain verbal consent from the patient and provide an information sheet to help explain study details/answer any questions. The patient will then be randomized to either warmed gel or room temperature gel. Investigators will handle the gel using a heat-resistant glove (ULine Terry Cloth Glove) to maintain blinding to the gel temperature. A bedside ultrasound study will then be performed by emergency physicians not otherwise involved in the study using the study gel. Immediately upon ultrasound completion, the patients will complete a satisfaction survey. The images from the study will be saved and subsequently reviewed by an emergency physician with fellowship training in ultrasound to score image quality from 1 (low) to 5 (high).

Conditions

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Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the investigators to handle the ultrasound gels.

Study Groups

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Heated gel

Patient undergoes ultrasound study using the intervention of heated ultrasound gel.

Group Type EXPERIMENTAL

Heated ultrasound gel

Intervention Type DEVICE

Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit).

Room temperature gel

Patient undergoes ultrasound study using the intervention of room temperature gel.

Group Type PLACEBO_COMPARATOR

Room temperature gel

Intervention Type DEVICE

Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off.

Interventions

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Heated ultrasound gel

Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit).

Intervention Type DEVICE

Room temperature gel

Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18-89 years
* Patients require bedside ultrasound

Exclusion Criteria

* Patients under age 18
* Patients over age 89
* Pregnant women
* Altered mental status
* Incarcerated
* Military basic trainees
* Primary language other than English
* Patients with open or broken skin over areas requiring ultrasound gel application

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes