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