## Protocol Section
### Identification Module
**NCT ID:** NCT03135379

**Acronym:** HUGS

**Brief Title:** 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

#### Organization Study ID Info
**ID:** C.2016.046d
#### Organization
**Class:** FED
**Full Name:** Brooke Army Medical Center
### Status Module
#### Completion Date
**Date:** 2017-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-06

**Type:** ACTUAL

**Last Update Submit Date:** 2017-11-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-08-06

**Type:** ACTUAL

**Results First Submit Date:** 2017-10-06

**Results First Submit QC Date:** 2017-11-09

#### Start Date
**Date:** 2016-04

**Type:** ACTUAL

**Status Verified Date:** 2017-11

#### Study First Post Date
**Date:** 2017-05-01
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-27
**Study First Submit QC Date:** 2017-04-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** Brooke Army Medical Center

#### Responsible Party

**Investigator Affiliation:** Brooke Army Medical Center

**Investigator Full Name:** Michael D. April

**Investigator Title:** Assistant Program Director for Research, Emergency Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Ultrasound

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the investigators to handle the ultrasound gels.

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 124

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient undergoes ultrasound study using the intervention of heated ultrasound gel.

**Intervention Names:**

- Device: Heated ultrasound gel

**Label:** Heated gel

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Device: Room temperature gel

**Label:** Room temperature gel

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Heated gel

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

**Name:** Heated ultrasound gel

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Room temperature gel

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

**Name:** Room temperature gel

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Patient Satisfaction

**Time Frame:** Immediately upon completion of ultrasound examination

#### Secondary Outcomes

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

**Measure:** Ultrasound Image Quality

**Time Frame:** Within 1 week of completion of ultrasound examination

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 89 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** benjamin.m.krainin.mil@mail.mil

**Name:** Benjamin M Krainin, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 21215554

**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.

**PMID:** 25439619

**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.

**PMID:** 9862594

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-04-22

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 155750

- Type Abbrev: Prot_SAP

- Upload Date: 2017-10-06T14:56

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Heated Gel

**Deaths Num At Risk:** 62

**Description:** 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).

**ID:** EG000

**Other Num at Risk:** 62

**Serious Number At Risk:** 62

**Title:** Heated Gel

**Group ID:** EG001

**Title:** Room Temperature Gel

**Deaths Num At Risk:** 62

**Description:** 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.

**ID:** EG001

**Other Num at Risk:** 62

**Serious Number At Risk:** 62

**Title:** Room Temperature Gel

**Frequency Threshold:** 0

**Time Frame:** 30 minutes

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 61

**Group ID:** BG001

**Value:** 59

**Group ID:** BG002

**Value:** 120

**Units:** Participants

### Group

**ID:** BG000

**Title:** Heated Gel

**Description:** 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).

### Group

**ID:** BG001

**Title:** Room Temperature Gel

**Description:** 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.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 17.6

**Value:** 41.5

#### Measurement

**Group ID:** BG001

**Spread:** 18.5

**Value:** 42.0

#### Measurement

**Group ID:** BG002

**Spread:** 18.0

**Value:** 41.7

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 61

**Group ID:** BG001

**Value:** 59

**Group ID:** BG002

**Value:** 120

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 32

#### Measurement

**Group ID:** BG002

**Value:** 51

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 42

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 69

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 61

**Group ID:** BG001

**Value:** 59

**Group ID:** BG002

**Value:** 120

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** Benjamin.M.Krainin.mil@mail.mil
**Organization:** Brooke Army Medical Center
**Phone:** 210-916-0808
**Title:** Benjamin M. Krainin
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 84.8
- **Spread:** 
- **Upper Limit:** 90.1
- **Value:** 87.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 79.4
- **Spread:** 
- **Upper Limit:** 87.6
- **Value:** 83.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Immediately upon completion of ultrasound examination
**Title:** Patient Satisfaction
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 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).
**ID:** OG000
**Title:** Heated Gel
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Room Temperature Gel
#### Outcome Measure 2
**Description:** Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Within 1 week of completion of ultrasound examination
**Title:** Ultrasound Image Quality
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 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).
**ID:** OG000
**Title:** Heated Gel
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Room Temperature Gel
### Participant Flow Module
#### Group
**Description:** 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).
**ID:** FG000
**Title:** Heated Gel
#### Group
**Description:** 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.
**ID:** FG001
**Title:** Room Temperature Gel
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 62
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 62
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 61
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 59
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Has Results:** True