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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heated gel | Experimental | Patient undergoes ultrasound study using the intervention of heated ultrasound gel. |
|
| Room temperature gel | Placebo Comparator | Patient undergoes ultrasound study using the intervention of room temperature gel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated ultrasound gel | Device | Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound Image Quality | Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship. | Within 1 week of completion of ultrasound examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin M Krainin, MD | benjamin.m.krainin.mil@mail.mil | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21215554 | Background | 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. | |
| 25439619 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heated Gel | Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). |
| FG001 | Room Temperature Gel | Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heated Gel | Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). |
| BG001 | Room Temperature Gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately upon completion of ultrasound examination |
|
30 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heated Gel | Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin M. Krainin | Brooke Army Medical Center | 210-916-0808 | Benjamin.M.Krainin.mil@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2016 | Oct 6, 2017 | Prot_SAP_000.pdf |
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A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the investigators to handle the ultrasound gels.
| Room temperature gel | Device | Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. |
|
| 9862594 | Background | 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. |
Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. |
|
|
| Secondary | Ultrasound Image Quality | Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship. | Posted | Median | Inter-Quartile Range | units on a scale | Within 1 week of completion of ultrasound examination |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Room Temperature Gel | Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. | 0 | 62 | 0 | 62 | 0 | 62 |
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