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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Michael D. April, 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.

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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135379


Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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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:

Publications:
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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    Key Record Dates
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

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