NCT03135379

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 6, 2018

Completed
Last Updated

August 6, 2018

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

April 27, 2017

Results QC Date

October 6, 2017

Last Update Submit

November 9, 2017

Conditions

Ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ultrasound Image Quality

    Within 1 week of completion of ultrasound examination

Study Arms (2)

Heated gel

EXPERIMENTAL

Patient undergoes ultrasound study using the intervention of heated ultrasound gel.

Device: Heated ultrasound gel

Room temperature gel

PLACEBO COMPARATOR

Patient undergoes ultrasound study using the intervention of room temperature gel.

Device: Room temperature gel

Interventions

Heated ultrasound gelDEVICE

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

Heated gel
Room temperature gelDEVICE

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

Room temperature gel

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-89 years
  • Patients require bedside ultrasound

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21215554BACKGROUND

  • 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.

    PMID: 25439619BACKGROUND

  • 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. doi: 10.1111/j.1553-2712.1998.tb02781.x.

    PMID: 9862594BACKGROUND

Results Point of Contact

Title
Benjamin M. Krainin
Organization
Brooke Army Medical Center
Benjamin.M.Krainin.mil@mail.mil
210-916-0808

Study Officials

  • Benjamin M Krainin, MD

    benjamin.m.krainin.mil@mail.mil

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the investigators to handle the ultrasound gels.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Program Director for Research, Emergency Medicine

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 1, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 6, 2018

Results First Posted

August 6, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share