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临床试验/NCT04812184
NCT04812184已完成不适用

Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use

Indiana University2 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
2
主要终点
Proper Face Mask Use up to 60 Minutes

研究概览

简要总结

Methods 123 patients were enrolled in a randomized controlled trial at Eskenazi Hospital from April 2020 until October 2020. We permitted patients to either use their own mask (due to low resources institutionally) or we provided a surgical/cloth mask (early on relied on donated cloth masks for patients). Patients were randomized to a control (no tape over the mask/nose) or to the intervention (placing tape over the bridge of the nose of the face mask). Patients were evaluated at 30- and 60- minute intervals to assess for proper mask usage.

详细描述

Study Design and Setting:

This study is a randomized control trial at Eskenazi Hospital ED from April 2020 until October 2020. Eskenazi Hospital is a busy, urban, academic hospital, level 1 trauma center, in downtown Indianapolis. Here we serve a racially diverse, underserved population, with over 100,000 annual ED visits. This work was approved by the Indiana University Institutional Review Board (protocol #2004425945).

Selection of Participants:

All patients presenting to the ED were screened for enrollment in this study by trained research personnel. All patients are required to wear facial coverings while in the ED, and after screening patients based on the exclusion criteria provided below, patients were offered enrollment in the study. Patients were randomly identified by their bed location in the ED via a random number generator. Patients were excluded from the study for: (1) pregnant; (2) prisoner; (3) not English or Spanish speaking (currently a large cohort of ethnic Latino/Latina/Hispanic are utilizing the ED and we can use interpreters to interpret for enrollment); (4) intoxicated or decompensated psychiatric illness; (5) presenting to the ED with a life-threatening condition; (6) allergic to standard tape and/or tegaderm. Patient consent was obtained if an individual agreed to participate in the study.

Interventions:

研究设计

研究类型
Interventional
分配方式
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

  • presenting to the emergency department during the covid-19 pandemic
  • older than 18 years of age

排除标准

  • not english speaking
  • not intoxicated or decompensated psychiatric illness
  • not critically ill
  • not allergic to standard tape and/or tegaderm

结局指标

主要结局

Proper Face Mask Use up to 60 Minutes

时间窗: 60 minutes on Day 1

The primary outcome of this trial is proper mask utilization upon reevaluation up to 60 minutes (with the mask at/under the chin, meanwhile completely covering the mouth and nose). At these time point a trained observer enters the room and observes the patient's face covering and its location on the face (correct, chin exposed, nose exposed, not on at all).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Pettit

Assistant Professor

Indiana University

研究点 (2)

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