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临床试验/NCT05229926
NCT05229926已完成不适用

Implementation of CareCube Negative Pressure Isolation Units in a High-Volume Tertiary Care Hospital: A Pilot Study

Saint Luke's Health System1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年3月27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
16
试验地点
1
主要终点
Completion of Nursing Assistant Task - Nasal Swab

研究概览

简要总结

Pilot study to provide a descriptive analysis of the real-world feasibility of using a CareCube for COVID-19 patients in a high-volume tertiary care hospital.

详细描述

The CareCube is a modular, disposable, negative pressure, isolation patient care system that can rapidly augment hospital's capacity to care for patients with contagious droplets or airborne pathogens. It is designed as a temporary single-use negative pressure isolation care unit with PPE for common patient care protocols built into the unit. The device is intended to be used in a healthcare setting as a temporary isolation of patients with suspected or confirmed diagnosis of COVID-19 to prevent Healthcare Practitioners (HCP) and patients' visitors from being exposed to pathogenic biological airborne particulates. The system includes three components: an isolation chamber, functional gown, and gloves. The isolation chamber functions in a similar manner to a hospital negative pressure, Airborne Infection Isolation Room. The gown and gloves provide an extra layer of barrier protection beyond PPE. The CareCube is designed to provide improved protection for front-line healthcare workers, while also conserving the vital supplies of N95 masks, face shields, and gowns, which are not required since there is no direct contact with the patient.

The goal of this project is to provide preliminary data to describe the experiences of 'patients', their caregivers, and providers with the CareCube.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Adult male or female previously hospitalized during the COVID-19 pandemic
  • At least 21 days post- positive COVID-19 test result
  • Able to provide written informed consent

排除标准

  • Under 18 years of age
  • Unable to provide written informed consent on own behalf

结局指标

主要结局

Completion of Nursing Assistant Task - Nasal Swab

时间窗: through study completion, one day

success of obtaining nasal swab as assessed by observer (successful/not successful)

Completion of Nursing Assistant Task - Obtain Patient Weight

时间窗: through study completion, one day

success of obtaining patient weight as assessed by observer (successful/not successful)

Completion of Nursing Assistant Task - Obtain Vital Signs

时间窗: through study completion, one day

success of obtaining vital signs as assessed by observer (successful/not successful)

Completion of Nursing Assistant Task - Attach Telemetry Stickers

时间窗: through study completion, one day

success of telemetry stickers attachment as assessed by observer (successful/not successful)

Completion of Nursing Assistant Task - Place Nasal Cannula

时间窗: through study completion, one day

success of nasal cannula O2 placement as assessed by observer (successful/not successful)

Completion of Nursing Assistant Task - Pass Through Tray

时间窗: through study completion, one day

success of passing a tray of food via pass-through to patient as assessed by observer (successful/not successful)

Completion of Nursing Assistant Task - Receive Tray

时间窗: through study completion, one day

success of collecting a tray of food/waste/ via pass-through from the patient as assessed by observer (successful/not successful)

Completion of Registered Nurse Task - Medications

时间窗: through study completion, one day

success of medicine reconciliation (generic medication questions, i.e., do you take an aspirin, etc.) with patient as assessed by observer (successful/not successful)

Completion of Registered Nurse Task - Place Nasal Cannula

时间窗: through study completion, one day

success of nasal cannula O2 placement as assessed by observer (successful/not successful)

Completion of Registered Nurse Task - Place Non-Rebreather Mask

时间窗: through study completion, one day

success of non-rebreather mask placement as assessed by observer (successful/not successful)

Completion of Registered Nurse Task - Place Intravenous Line

时间窗: through study completion, one day

success of intravenous line placement as assessed by observer (successful/not successful)

Completion of CRNA Task (Mannequin) - Intubation

时间窗: through study completion, one day

success of intubation as assessed by observer (successful/not successful)

Completion of CRNA Task (Mannequin) - Attach Defibrillator Pads

时间窗: through study completion, one day

success of external defibrillator pad placement as assessed by observer (successful/not successful)

次要结局

  • Caregiver Satisfaction(through study completion, one day)
  • Healthcare Provider Satisfaction(through study completion, one day)
  • Patient Experience of Claustrophobia(through study completion, one day)
  • Patient Experience of Stress and Anxiety(through study completion, one day)
  • Patient Satisfaction(through study completion, one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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