Nasal Compression Device Study for Epistaxis

Epistaxis Nosebleed Clinical Trial

Official title:

Feasibility Study of a Nasal Compression Device in Comparison to Digital Nasal Compression for Stopping Epistaxis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789264
• Other study ID #: EMI001
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: NasaClip
• Contact: Wilner Jeudy, Dr.
• Phone: 281-612-3600
• Email: wjeudy[@]nextlevelurgentcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will explore how a nasal compression device compares to manual compression for stopping anterior nosebleeds. This will be a non-randomized controlled trial enrolling participants presenting to medical care for anterior nosebleeds. Participants will be assigned to receive either a nasal compression device or standard of care consisting of digital compression. Participants will be asked to complete survey questions to assess satisfaction with the care they received, comfort, and overall experience with the device.

Description:

This will be a non-randomized controlled trial study design. Alternating assignments will be made to either the nasal compression device arm or standard of care (manual nasal compression with pinching) arm. Patients with anterior nosebleeds and not meeting any exclusion criteria will be identified upon registration at the study locations. The patient will be approached by a study team member who will briefly inform the patient about the study and invite the patient to participate. If the patient agrees to participate, they will be assigned to either the nasal compression device arm or the standard of care arm. Participants will then undergo a brief medical screening by a medical provider during the triage process to ensure no exclusion criteria are present. A study information sheet including key information, risks and benefits, and study team contact information will be provided for the patient to review while they are receiving treatment. Patients will be allowed to end their participation in the study at any time. Participants will then be assessed every 5-10 minutes by a study team member to evaluate if bleeding has resolved. If a participant is still bleeding during a bleeding check they will be supplied a new device/gauze to avoid having to reuse bloodied material. If bleeding has not resolved after 30 minutes of wearing the nasal compression device or with digital pressure, this will be defined as a treatment failure and patients will receive second line therapies at the discretion of the medical provider. Participants in the device arm will be provided with a NasaClip device upon discharge from the study site and all participants will be contacted 48 hours later to determine if they had further epistaxis at home, whether they used the device if given one, ease of application at home, and whether it was successful.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION In order to be eligible to participate in this study, an individual must meet all of the

following criteria:

1. Presenting with anterior epistaxis determined as someone with venous bleeding that can be controlled with external compression.

2. Stated willingness to comply with all study procedures and availability for the duration of the study.

3. Male or female, aged at least 18.

4. In good general health as determined by the PI or Sub-I(s). EXCLUSION An individual who meets any of the following criteria will be excluded from participation

in this study:

1. Known allergic or hypersensitivity reactions to components of NasaClip or oxymetazoline.

2. Less than 18 years of age.

3. Known pregnancy.

4. Unable to provide informed consent.

5. Subjects who are prisoners or who are in police custody.

6. Identified by the medical team as having an acute exacerbation or poor control of any of the following medical conditions: high blood pressure, heart disease, thyroid disease, diabetes, trouble urinating due to an enlarged prostate.

7. Patients taking MAO inhibitors.

8. Medical instability or need for emergent intervention as determined by on-site medical team.

Related Conditions & MeSH terms

• Epistaxis
• Epistaxis Nosebleed

Intervention

Device:
• Nasal Compression Device
Participants assigned to the NasaClip arm will not receive routine care as the objective of this study is to compare the NasaClip device to routine digital compression in terms of feasibility, comfort, and efficacy. Limited data previously discussed in the background section indicates that application of nasal compression devices may be superior to digital compression.

Diagnostic Test:
• Routine Care
Most first aid instructions for epistaxis management tell patients to apply firm digital pressure for 10 to 20 minutes, use a topical vasoconstrictor and apply an ice pack over the nose.

Locations

Country	Name	City	State
United States	Next Level Urgent Care	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NasaClip

Country where clinical trial is conducted

United States, 

References & Publications (10)

Bende M, Loth S. Vascular effects of topical oxymetazoline on human nasal mucosa. J Laryngol Otol. 1986 Mar;100(3):285-8. doi: 10.1017/s0022215100099151. — View Citation

Bequignon E, Teissier N, Gauthier A, Brugel L, De Kermadec H, Coste A, Pruliere-Escabasse V. Emergency Department care of childhood epistaxis. Emerg Med J. 2017 Aug;34(8):543-548. doi: 10.1136/emermed-2015-205528. Epub 2016 Aug 19. — View Citation

Doo G, Johnson DS. Oxymetazoline in the treatment of posterior epistaxis. Hawaii Med J. 1999 Aug;58(8):210-2. — View Citation

Gifford TO, Orlandi RR. Epistaxis. Otolaryngol Clin North Am. 2008 Jun;41(3):525-36, viii. doi: 10.1016/j.otc.2008.01.003. — View Citation

Guarisco JL, Graham HD 3rd. Epistaxis in children: causes, diagnosis, and treatment. Ear Nose Throat J. 1989 Jul;68(7):522, 528-30, 532 passim. — View Citation

Kucik CJ, Clenney T. Management of epistaxis. Am Fam Physician. 2005 Jan 15;71(2):305-11. — View Citation

Padgham N. Epistaxis: anatomical and clinical correlates. J Laryngol Otol. 1990 Apr;104(4):308-11. doi: 10.1017/s0022215100112563. — View Citation

Schlosser RJ. Clinical practice. Epistaxis. N Engl J Med. 2009 Feb 19;360(8):784-9. doi: 10.1056/NEJMcp0807078. No abstract available. — View Citation

Traboulsi H, Alam E, Hadi U. Changing Trends in the Management of Epistaxis. Int J Otolaryngol. 2015;2015:263987. doi: 10.1155/2015/263987. Epub 2015 Aug 16. — View Citation

Tunkel DE, Anne S, Payne SC, Ishman SL, Rosenfeld RM, Abramson PJ, Alikhaani JD, Benoit MM, Bercovitz RS, Brown MD, Chernobilsky B, Feldstein DA, Hackell JM, Holbrook EH, Holdsworth SM, Lin KW, Lind MM, Poetker DM, Riley CA, Schneider JS, Seidman MD, Vadlamudi V, Valdez TA, Nnacheta LC, Monjur TM. Clinical Practice Guideline: Nosebleed (Epistaxis). Otolaryngol Head Neck Surg. 2020 Jan;162(1_suppl):S1-S38. doi: 10.1177/0194599819890327. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome - Change over time from full epistaxis to cessation.	Primary outcome is time to bleeding cessation.	Checked at 10 min intervals for a total of 3 intervals (30 min).

External Links

•   Approach to the adult with epistaxis - UpToDate
•   Epistaxis: Practice Essentials, Anatomy, Pathophysiology