Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-09-26
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
Participants assigned to the standard of care arm will be guided through clearing out clots in the nose (if using oxymetazoline), correct head positioning and how to appropriately hold nasal pressure and +/- oxymetazoline applied by a trained medical provider. No packing material will be inserted into the nares and only external pressure will be applied.
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.
Nasal Compression Device
Participants assigned to the nasal compression device arm will be provided with the device package which will include the compression device, nasal sponges, and +/- oxymetazoline nasal spray to apply to the sponges as well as written/graphical assembly and application instructions. Participants will then assemble and apply the device themselves under the supervision of a trained medical provider.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion 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.
18 Years
ALL
Yes
Sponsors
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NasaClip
INDUSTRY
Responsible Party
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Locations
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Next Level Urgent Care
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Padgham N. Epistaxis: anatomical and clinical correlates. J Laryngol Otol. 1990 Apr;104(4):308-11. doi: 10.1017/s0022215100112563.
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.
Gifford TO, Orlandi RR. Epistaxis. Otolaryngol Clin North Am. 2008 Jun;41(3):525-36, viii. doi: 10.1016/j.otc.2008.01.003.
Schlosser RJ. Clinical practice. Epistaxis. N Engl J Med. 2009 Feb 19;360(8):784-9. doi: 10.1056/NEJMcp0807078. No abstract available.
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.
Kucik CJ, Clenney T. Management of epistaxis. Am Fam Physician. 2005 Jan 15;71(2):305-11.
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.
Doo G, Johnson DS. Oxymetazoline in the treatment of posterior epistaxis. Hawaii Med J. 1999 Aug;58(8):210-2.
Related Links
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Approach to the adult with epistaxis - UpToDate
Epistaxis: Practice Essentials, Anatomy, Pathophysiology
Other Identifiers
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EMI001
Identifier Type: -
Identifier Source: org_study_id