跳至主要内容
临床试验/NCT05789264
NCT05789264招募中不适用

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

NasaClip2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Primary Outcome - Change over time from full epistaxis to cessation.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • In good general health as determined by the PI or Sub-I(s).
  • 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.

排除标准

  • 未提供

结局指标

主要结局

Primary Outcome - Change over time from full epistaxis to cessation.

时间窗: Checked at 10 min intervals for a total of 3 intervals (30 min).

Primary outcome is time to bleeding cessation.

次要结局

未报告次要终点

研究者

发起方
NasaClip
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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