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OpenTrials
Completed

NCT Number: NCT03135379

Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel

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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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heated ultrasound gel

Device

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

Room temperature gel

Device

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

Primary outcomes

  1. Patient Satisfaction

    Time frame: 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 outcomes

  1. Ultrasound Image Quality

    Time frame: Within 1 week of completion of ultrasound examination

    Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

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

Acronym: HUGS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 1, 2017
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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