Highflow nasal cannula versus noninvasive ventilation in the prevention of escalation to invasive mechanical ventilation in patients with acute hypoxemic respiratory failure. A Randomised Comparative Interventional Study at SMS Medical College
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To Assess Need for Invasive Mechanical Ventilation In Patients of Acute Hypoxemic Respiratory Failure.
研究概览
简要总结
Patients with AHRF will be admitted to ICU.
Sample of patients satisfying the inclusion criteria will be selected for study and patients will be randomized into two groups by computer random number table method.
Patients will be assigned to NIV or HFNC.
Patient assigned NIV will be connected to ventilator for conventional NIV with full mask with following ventilator settings with PEEP 2 to 10 cm of water initially later PEEP or FiO2 or both will be set to keep SaO2≥92%. Ps level will be set to achieve expiratory tidal volume of 7 to 10 ml/kg.
Patient of other group will be connected to HFNC and heated humidified oxygen 31-37 C will be continuously supplied through binasal large bore prongs. Initial setting of oxygen flow rate will be 50L/min and FiO21.0, later setting of Fio2will be adjusted to attain SaO2≥92%
Following parameter will be recorded in both groups
- Total number of patients in percentage will be required need of intubation due to following reasons
pH < 7.20
paO2 <45mmHg
paCO2 >60mmHg
Cardiopulmonary arrest
-
To Measure Vital parameters (SBP, DBP, MAP, HR, RR, SPO2) at inclusion and at 12, 24, 36, 48, 60, 72 hours.
-
To Assess Respiratory Acidosis by recording ABG at 1, 6, 24, 48 hours of study treatment.
-
To Assess no. of days on HFNC/NIV before escalation to intubation.
-
To Assess no. of duration of ICU stay.
-
To Measure Hospital Mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to give consent Patients having AHRF defined by PaO2/FiO2 less than or equal to 300mmhg Patient not responding to conventional oxygen therapy Patient requiring ventilator support due to increased respiratory rate.
排除标准
- •Absolute indication for intubation Contraindication to NIV PaCO2 more than 45mmhg Chronic respiratory failure.
结局指标
主要结局
To Assess Need for Invasive Mechanical Ventilation In Patients of Acute Hypoxemic Respiratory Failure.
时间窗: until Invasive Mechanical Ventilation
次要结局
- 1.To measure vital parameters (SBP, DBP, MAP, HR, RR, SPO2)(2.To assess respiratory acidosis by recording ABG.)
研究者
Dr Nihar Sharma
Sms medical college