Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel

Study Overview
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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.

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).

Official Title
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Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial

Conditions
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Ultrasound

Intervention / Treatment
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* Device: Heated ultrasound gel
* Device: Room temperature gel


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heated gel<br>Patient undergoes ultrasound study using the intervention of heated ultrasound gel. | Device: Heated ultrasound gel<br>* Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to medium setting (102 degree fahrenheit).<br>|
| Placebo Comparator: Room temperature gel<br>Patient undergoes ultrasound study using the intervention of room temperature gel. | Device: Room temperature gel<br>* Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Measured on 100-mm visual analogue scale. This scale is a horizontal line on a sheet of paper measuring 100 mm. The scale ranges from 0 on the left (representing completely unsatisfied) to 100 on the right (representing completely satisfied). We instructed subjects to draw a single vertical mark through the horizontal line to represent how satisfied they were with their overall emergency department visit. | Immediately upon completion of ultrasound examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound Image Quality | Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship. | Within 1 week of completion of ultrasound examination |