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临床试验/NCT04761679
NCT04761679终止不适用

Nasal Bridge Pressure Injury Prevention Using Protective Dressing and Halyard Fluidshield N95 Mask

Columbia University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
Number of Participants with Pressure Injury Prevention

研究概览

简要总结

The primary goal of this study is to explore whether applying the Mepilex foam on the nasal bridge directly between the skin and the N95 mask will prevent nasal bridge pressure injury among nursing staff, secondary to long-term ( >8+ hours) wear time. The secondary goal is to evaluate if using the Mepilex maintains the seal of the mask.

详细描述

Nurses use the N95 Mask as part of the personal protective equipment (PPE) when caring for patients with COVID-19. The N95 mask covers their nose and mouth with a tight seal. Nurses wear the mask for more than 8 hours per day, as a result they are at increased risk for skin injury on the nasal bridge. Mepliex is foam dressing which has been used to prevent pressure injuries to the skin. This study will evaluate if using Mepilex or band-aid on the nasal bridge of the nurses who wear the N95 for more than 8 hours decreases the potential for skin injury. In addition, the investigators will test if the Mepilex or band-aid also maintains the seal of the mask. Maintaining the seal is important to ensure that the nurse is not exposed to the virus. The investigators will be working with nurses who do not directly take care of COVID-19 patients to ensure the safety of all participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Single-blind design

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The sample will consist of nursing staff working on non-COVID units, including: Medical Surgical Units, Operating Rooms or Ambulatory Care- Labor and Delivery Unit, Maternity Unit and Medical Oncology Unit, at NewYork-Presbyterian (NYP) Lawrence Hospital.

排除标准

  • Exclusion Criteria: A score on > 5 the COVID Anxiety Scale. The scale has 4 questions with 5 possible options (rated 1 - 5), to evaluate the effect of COVID19 on the individual. The lowest possible score is 0, the highest possible score is
  • A score of 5 states that the individual experiences COVID19 related anxiety for 'Rarely' or 'Not at All". Excluding participants with a score of > 5 will prevent unnecessary harm to study participants or exacerbate symptoms of anxiety.
  • Nurses working in the Emergency Department, Intensive Care Unit or a unit with a focus on the exposed COVID-19 population
  • Non-clinical nurses, volunteer or agency registered nurses
  • Known history of skin breakdown or damage to the nasal bridge
  • History of skin-related conditions including (acne vulgaris, Psoriasis, Herpetic lesions to mouth, nasal areas)
  • History of surgery to nasal bridge
  • Pregnant nurses in their third trimester
  • History of respiratory extended respirator use in addition to the hours collected in this study.

结局指标

主要结局

Number of Participants with Pressure Injury Prevention

时间窗: 48 hours

Researchers will count the number of participants with and without injury on the nasal bridge directly between the skin and the N95 mask

次要结局

  • Number of Participants that Maintain Mask Seal Integrity(12 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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