Effect of proning in patients with COVID-19 acute hypoxemic respiratory failure receiving non-invasive oxygen therapy: A prospective cohort study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To study the rate of invasive mechanical ventilation in patients treated with awake proning along with non-invasive methods of oxygen delivery in patients of COVID -19 positive acute hypoxemic respiratory failure
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, Hubei Province China, and has subsequently spread worldwide in more than 200 countries including India. Although majority of patients have a favourable prognosis, the older age group, and presence of chronic diseases have been reported to have worse outcomes. Severe illness is marked by development of dyspnea, hypoxemia and progression to acute respiratory distress syndrome (ARDS) within one week of onset of symptoms (1). The most documented reason for requiring intensive care has been respiratory support, of which two-thirds of patients have met criteria for acute respiratory distress syndrome. Care of critically ill patients of COVID 19 is resource intensive, especially important in developing nations like India. Use of non-invasive methods of oxygen deliverywith high flow nasal cannula(2) and non-invasive ventilation(3,4) is an option in mild to moderate ARDS and may reduce the need for invasive mechanical ventilation. Any intervention which may result in reducing the need for intubation and mechanical ventilation can have a major impact in resource conservation in a pandemic situation.The aim of our study is to determine whether the early use of prone positioning (PP) combined with oxygen by non-rebreather mask (NRBM), non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) can avoid the need for intubation mild to moderate ARDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •a)All adults > 18 years of age with acute hypoxemic respiratory failure with room air saturation < 93% or PaO2/ FiO2 ≤300 AND b)COVID -19 positive by RT- PCR or COVID-19 suspected as the most probable clinco-radiological diagnosis of acute respiratory failure.
排除标准
- •Age <18 yrs or >70 yrs; 2)Severe ARDS P/F < 100mmHg 3)PaCO2 >50 mm Hg; 4)Glasgow Coma Scale <11; 5)Unable to spontaneously clear secretions from the airways 6)Requirement of emergency intubation for cardiopulmonary resuscitation, respiratory arrest, severe hemodynamic instability 7)Refusal to receive NPPV/ HFNC/ NRBM 8)Unable to cooperate with NPPV/ HFNC/ NRBM application 9)Pregnancy.
结局指标
主要结局
To study the rate of invasive mechanical ventilation in patients treated with awake proning along with non-invasive methods of oxygen delivery in patients of COVID -19 positive acute hypoxemic respiratory failure
时间窗: till discharge or intubation
次要结局
- 1.To study the improvement in oxygenation parameters (SO2, SO2/ FiO2, PaO2/ FiO2 ratio and ROX index) in patients undergoing prone positioning(2.Duration of hospital stay)
