UltrasoundHUGSNCT03135379
Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel
A study testing Heated ultrasound gel and Room temperature gel in people with Ultrasound, run by Brooke Army Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound
- What is being tested?
- Heated ultrasound gel and Room temperature gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-89 years
- Patients require bedside ultrasound
Who cannot join
- 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
About this study
Official title: Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial
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.
Read the 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
- Ultrasound
- Being tested
- Heated ultrasound gel, Room temperature gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated ultrasound gelDevice
Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit).
Room temperature gelDevice
Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off.
| Study group | Role | What they receive |
|---|---|---|
| Heated gel | Experimental | Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Receives: Device: Heated ultrasound gel |
| Room temperature gel | Placebo comparator | Patient undergoes ultrasound study using the intervention of room temperature gel. Receives: Device: Room temperature gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately upon completion of ultrasound examination
Secondary outcomes (1)
Ultrasound Image Quality
Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.
Measured: Within 1 week of completion of ultrasound examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startApr 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael D. April, Brooke Army Medical Center
- Investigators
- Benjamin M Krainin, MD, Principal investigator, benjamin.m.krainin.mil@mail.mil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135379
- Sponsor's protocol ID
- C.2016.046d
- Acronym
- HUGS
- Status last verified
- Nov 2017
- First submitted
- 27 Apr 2017
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21215554Levin 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.
PubMed 25439619Singer 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.
PubMed 9862594
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03135379
- Acronym / sponsor ID
- HUGS / C.2016.046d
- Conditions
- Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 6 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heated gel | Experimental | Device: Heated ultrasound gelPatient undergoes ultrasound study using the intervention of heated ultrasound gel. |
| Room temperature gel | Placebo comparator | Device: Room temperature gelPatient undergoes ultrasound study using the intervention of room temperature gel. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18-89 years
- Patients require bedside ultrasound
Key exclusion criteria (8 listed)
- Patients under age 18
- Patients over age 89
- Pregnant women
- Altered mental status
- Incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heated ultrasound gelGel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). | Device | Heated gel |
| Room temperature gelGel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. | Device | Room temperature gel |
Primary outcome
Patient Satisfaction
Time frame: 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.
1 secondary outcome
Ultrasound Image Quality
Time frame: Within 1 week of completion of ultrasound examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21215554Cydulka 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.
- Background: PubMed 25439619Levin 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.
- Background: PubMed 9862594Singer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Krainin, MD principal investigator
benjamin.m.krainin.mil@mail.mil
Questions about this trial
What is this clinical trial studying?
A study testing Heated ultrasound gel and Room temperature gel in people with Ultrasound, run by Brooke Army Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Immediately upon completion of ultrasound examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135379, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.