Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel

Not Applicable

Completed

• Conditions: Ultrasound
• Interventions: Device: Heated ultrasound gel; Device: Room temperature gel

• Registration Number: NCT03135379
• Lead Sponsor: Brooke Army Medical Center

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-01
• Results First Submitted: 2017-10-06
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-09
• Last Update Submitted: 2017-11-09
• Results First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heated gel	Heated ultrasound gel	Patient undergoes ultrasound study using the intervention of heated ultrasound gel.
Room temperature gel	Room temperature gel	Patient undergoes ultrasound study using the intervention of room temperature gel.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	Immediately upon completion of ultrasound examination	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.

Secondary Outcome Measures

Name	Time	Method
Ultrasound Image Quality	Within 1 week of completion of ultrasound examination	Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.