Ultrasound
Conditions
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).
Interventions
DEVICEHeated ultrasound gel
Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to medium setting (102 degree fahrenheit).
DEVICERoom temperature gel
Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off.
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound Image Quality | Within 1 week of completion of ultrasound examination | Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 61 |
| 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. | 59 |
| Total | 120 |
Baseline characteristics
| Characteristic | Heated Gel | Room Temperature Gel | Total |
|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 17.6 | 42.0 years STANDARD_DEVIATION 18.5 | 41.7 years STANDARD_DEVIATION 18 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 32 Participants | 51 Participants |
| Sex: Female, Male Male | 42 Participants | 27 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 62 |
| other Total, other adverse events | 0 / 62 | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 | 0 / 62 |
Outcome results
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.
Time frame: Immediately upon completion of ultrasound examination
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Heated Gel | Patient Satisfaction | 87.6 units on a scale |
| Room Temperature Gel | Patient Satisfaction | 83.9 units on a scale |
Secondary
Ultrasound Image Quality
Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.
Time frame: Within 1 week of completion of ultrasound examination
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Heated Gel | Ultrasound Image Quality | 4 units on a scale |
| Room Temperature Gel | Ultrasound Image Quality | 4 units on a scale |