Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel (HUGS)

• ClinicalTrials.gov Identifier: NCT03135379
• Recruitment Status: Completed
• First Posted: May 1, 2017
• Results First Posted: August 6, 2018
• Last Update Posted: August 6, 2018
• Sponsor: Brooke Army Medical Center
• Information provided by (Responsible Party): Michael D. April, Brooke Army Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ultrasound	Device: Heated ultrasound gel; Device: Room temperature gel	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the investigators to handle the ultrasound gels.
• Primary Purpose: Diagnostic
• Official Title: Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: April 2017
• Actual Study Completion Date: April 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Brooke Army Medical Center

Investigators

• Principal Investigator: Benjamin M Krainin, MD; benjamin.m.krainin.mil@mail.mil

  Study Documents (Full-Text)

Documents provided by Michael D. April, Brooke Army Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] April 22, 2016

More Information

Publications:

Cydulka RK, Tamayo-Sarver J, Gage A, Bagnoli D. Association of patient satisfaction with complaints and risk management among emergency physicians. J Emerg Med. 2011 Oct;41(4):405-11. doi: 10.1016/j.jemermed.2010.10.021. Epub 2011 Jan 7.

Levin DC, Rao VM, Parker L, Frangos AJ. Continued growth in emergency department imaging is bucking the overall trends. J Am Coll Radiol. 2014 Nov;11(11):1044-7. doi: 10.1016/j.jacr.2014.07.008. Epub 2014 Nov 3.

Singer AJ, Thode HC Jr. Determination of the minimal clinically significant difference on a patient visual analog satisfaction scale. Acad Emerg Med. 1998 Oct;5(10):1007-11.

• Responsible Party: Michael D. April, Assistant Program Director for Research, Emergency Medicine, Brooke Army Medical Center
• ClinicalTrials.gov Identifier: NCT03135379
• Other Study ID Numbers: C.2016.046d
• First Posted: May 1, 2017
• Results First Posted: August 6, 2018
• Last Update Posted: August 6, 2018
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No