Trial Outcomes & Findings for Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel (NCT NCT03135379)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

124 participants

Primary outcome timeframe

Immediately upon completion of ultrasound examination

Results posted on

2018-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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.
Overall Study STARTED	62	62
Overall Study COMPLETED	61	59
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heated Gel n=61 Participants 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).	Room Temperature Gel n=59 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.	Total n=120 Participants Total of all reporting groups
Age, Continuous	41.5 years STANDARD_DEVIATION 17.6 • n=61 Participants	42.0 years STANDARD_DEVIATION 18.5 • n=59 Participants	41.7 years STANDARD_DEVIATION 18.0 • n=120 Participants
Sex: Female, Male Female	19 Participants n=61 Participants	32 Participants n=59 Participants	51 Participants n=120 Participants
Sex: Female, Male Male	42 Participants n=61 Participants	27 Participants n=59 Participants	69 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Heated Gel n=61 Participants 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).	Room Temperature Gel n=59 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.
Patient Satisfaction	87.6 units on a scale Interval 84.8 to 90.1	83.9 units on a scale Interval 79.4 to 87.6

SECONDARY outcome

Timeframe: Within 1 week of completion of ultrasound examination

Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.

Outcome measures

Outcome measures
Measure	Heated Gel n=40 Participants 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).	Room Temperature Gel n=39 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.
Ultrasound Image Quality	4 units on a scale Interval 3.0 to 4.0	4 units on a scale Interval 4.0 to 4.0

Adverse Events

Heated Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Room Temperature Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin M. Krainin

Brooke Army Medical Center

Phone: 210-916-0808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place