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临床试验/NCT04929691
NCT04929691Unknown不适用

The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Using an Implementation Research Framework

New York University9 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2020年11月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
370
试验地点
9
主要终点
Respiratory rate

研究概览

简要总结

The purpose of the CircumVent Project is to evaluate the feasibility, adaptability and acceptability of a CPAP/O2 helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria.

详细描述

Acute respiratory failure, a major cause of death in COVID-19, is managed with high-flow oxygen therapy via invasive mechanical ventilation. In resource-limited settings like Nigeria the shortage of ventilators and oxygen supply make this option challenging. Evidence-based non-invasive alternatives to mechanical ventilation such as the use of continuous positive airway pressure (CPAP) devices exist, but there have been concerns that non-invasive ventilation may expose healthcare workers to infection from aerosolized dispersion of SARS-CoV-2. The investigators propose to evaluate the feasibility, adaptability and acceptability of a CPAP/O2 helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria.

The study will occur in 4 stages: 1) Convene a Steering Committee of key stakeholders and recruit implementation sites; 2) Use the integrated Promoting Action on Research Implementation in Health Services (i-PARiHS) framework to guide a needs assessment of treatment centers' capacity to use high-flow oxygen therapy to treat COVID-19 patients, and utilize the findings to develop an implementation strategy for use of CPAP/ O2 helmet solution; 3) Build infrastructure to support training and data monitoring processes and to develop implementation protocols to evaluate the adaptability of the strategy for the use of the CPAP/O2 helmet; and 4) Train health workers, distribute a CPAP/O2 helmet solution for non-invasive ventilation, pilot test the implementation strategy, and assess feasibility of its use and acceptability that includes monitoring altered risk of SARS-CoV-2 infection among healthcare workers.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients admitted to a study site with respiratory distress and suspected or confirmed COVID-19 infection

排除标准

  • Patients who do not meet eligibility criteria

结局指标

主要结局

Respiratory rate

时间窗: 1-4 weeks while on admission

mild, 11-19/min; moderate, 20-24/min; severe, 25-30/min; very severe, \>30 or \<=10/min

Disposition

时间窗: 1-4 weeks while on admission

Died; Improved; Intubated

Pulse Oximetry

时间窗: 1-4 weeks while on admission

mild \>90; moderate \<=90; severe, \<88

次要结局

  • Adaptability of the strategy for implementing CPAP/O2 helmet solution(1-4 weeks while on admission)
  • Feasibility of using CPAP/O2 helmet solution(1- 4 weeks while on admission)
  • Acceptability of CPAP/O2 helmet solution for non-invasive management of COVID-19(1-4 weeks while on admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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