NCT05789264

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 26, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

February 26, 2023

Last Update Submit

November 20, 2023

Conditions

Epistaxis Nosebleed

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Diagnostic Test: Routine Care

Nasal Compression Device

EXPERIMENTAL

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.

Device: Nasal Compression Device

Interventions

Nasal Compression DeviceDEVICE

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.

Nasal Compression Device
Routine CareDIAGNOSTIC_TEST

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.

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Presenting with anterior epistaxis determined as someone with venous bleeding that can be controlled with external compression.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged at least 18.
  • In good general health as determined by the PI or Sub-I(s).

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Known allergic or hypersensitivity reactions to components of NasaClip or oxymetazoline.
  • Less than 18 years of age.
  • Known pregnancy.
  • Unable to provide informed consent.
  • Subjects who are prisoners or who are in police custody.
  • 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.
  • Patients taking MAO inhibitors.
  • Medical instability or need for emergent intervention as determined by on-site medical team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Next Level Urgent Care

Houston, Texas, 77057, United States

RECRUITING

Related Publications (10)

  • 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.

    PMID: 26351457BACKGROUND

  • 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.

    PMID: 27542804BACKGROUND

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

    PMID: 2370452BACKGROUND

  • 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.

    PMID: 2676467BACKGROUND

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

    PMID: 18435996BACKGROUND

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

    PMID: 19228621BACKGROUND

  • 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.

    PMID: 3950497BACKGROUND

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

    PMID: 15686301BACKGROUND

  • 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.

    PMID: 31910111BACKGROUND

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

    PMID: 10487000BACKGROUND

Related Links

Central Study Contacts

Wilner Jeudy, Dr.

CONTACT

281-612-3600wjeudy@nextlevelurgentcare.com

Micko Sandford

CONTACT

281-612-3600msandford@nextlevelurgentcare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 29, 2023

Study Start

September 26, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)