Oxygen Requirements and Approaches to Respiratory Support in Patients With COVID-19 in LMICs: A WHO Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Proportion of patients receiving oxygen via each of various delivery devices.
研究概览
简要总结
This observational cohort study will enroll patients in LMICs with suspected or confirmed COVID-19 on oxygen or deemed to require oxygen therapy based on objective criteria. Demographics and risk factor information will be collected from participants. Participants will be followed for 7 days or until outcome (hospital discharge or death). Facility level metrics on oxygen availability will also be collected at the beginning of site enrolment.
详细描述
The COVID-19 pandemic has highlighted, more than ever, the acute need for scale up of oxygen therapy. WHO has provided an inventory tool to quantify facility-level provision of infrastructure to deliver oxygen therapy. However, data on the use of oxygen therapy at the patient-level remains lacking. This observational cohort study will enroll patients in LMICs with suspected or confirmed COVID-19 on oxygen or deemed to require oxygen therapy based on objective criteria. Demographics and risk factor information will be collected from participants. Participants will be followed for 7 days or until outcome (hospital discharge or death). Facility level metrics on oxygen availability will also be collected at the beginning of site enrolment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected SARS-CoV-2 infection as determined by treating clinical provider, or confirmed SARS-CoV-2 infection confirmed virologically in the lab by RT-PCR via nasopharyngeal or oropharyngeal sample or by SARS-CoV-2 Ag-RDTs that meet the minimum performance requirements of ≥80% sensitivity and ≥97% specificity compared to a NAAT reference assay.
- •Receiving supplemental oxygen or showing clinical evidence of need for supplemental respiratory support as reflected in a respiratory rate ≥30 breaths per minute or an SpO2 ≤ 90%, SpO2 < 94 % if any emergency signs are present
- •Admitted to health care facility
排除标准
- •Is not receiving oxygen or does not have clinical criteria for oxygen treatment specified above oxygen therapy
- •Does not have suspected or confirmed COVID-19 (as per criteria above)
- •Patient younger than 12 years of age
- •Lack of commitment to full supportive care
结局指标
主要结局
Proportion of patients receiving oxygen via each of various delivery devices.
时间窗: Over first 7 days of hospitalization
Oxygen delivery devices analysed: nasal cannulae, face mask, Venturi, NRB, HFNO, CPAP, NIV, IMV
Proportion of patients progressing to invasive mechanical ventilation
时间窗: Over first 7 days of hospitalization
If available at facility
Total oxygen requirements in patients receiving oxygen via each of various delivery devices.
时间窗: Over first 7 days of hospitalization
Daily oxygen use measured in liters. For nasal cannula, facemask, and non-rebreather FiO2 is assumed to be 1.0 and flow rates are adjustable in liters per minute. Liter per day consumption of O2 = device flow rate L/minute x 60 minutes/hr x 24 hr/day For high flow nasal cannula FiO2 is adjustable (defaulted to 1.0) and flow rate is adjustable in liters per minute. Liter per day consumption of O2 = device flow rate L/minute x 60 minutes/hr x 24 hr/day; flow rate in LPM = device flow rate x (FiO2 - 0.21)/0.79 For ventilator, CPAP, BIPAP/NIPPV FiO2 is adjustable (defaulted to 1.0) and flow rate is adjustable in liters per minute and dependent on multiple factors. Liter per day consumption of O2 = device O2 consumption rate L/minute x 60 minutes/hr x 24 hr/day Device O2 consumption rate in LPM = (Minute ventilation + (bias flow x RR x expiratory time/60) + leak) x (FiO2 - 0.21)/0.79
次要结局
- Demographics and outcomes at hospital discharge of cohort of hospitalized patients(Until patient discharge from hospital or death, censored at 30 days.)
- Quantification of total oxygen supply at each facility(One time at beginning of enrolment)
研究者
Pryanka Relan
Technical officer
World Health Organization