Clinical trial NCT03135379: Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel
Official title: Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-05-01
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility 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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Immediately upon completion of ultrasound examination
Secondary outcomes:
measure: Ultrasound Image Quality
timeFrame: Within 1 week of completion of ultrasound examination
Other outcomes:
Locations:
Study officials:
affiliation: benjamin.m.krainin.mil@mail.mil
name: Benjamin M Krainin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.