Nasal Compression Device Study for Epistaxis

Not Applicable

Recruiting

• Conditions: Epistaxis Nosebleed

• Registration Number: NCT05789264
• Lead Sponsor: NasaClip

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-29
• Study Start: 2023-09-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-05
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Outcome - Change over time from full epistaxis to cessation.	Checked at 10 min intervals for a total of 3 intervals (30 min).	Primary outcome is time to bleeding cessation.

Trial Locations

Locations (1)

Next Level Urgent Care; 🇺🇸 Houston, Texas, United States