跳至主要内容
临床试验/CTRI/2024/10/074936
CTRI/2024/10/074936尚未招募不适用

Comparison of ROX index with HACOR scale in predicting success of high-flow nasal cannula in acute hypoxemic respiratory failure.

VMMC and SAFDARJUNG HOSPITAL1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年10月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Primary outcome was defined as no intolerance requiring hfnc removal and no escalation to invasive or non invasive ventilation within 48 hours after hfnc application i.e HFNC will be terminated if any of the following criteria for termination is met adopted from British thoracic guidelines; respiratory rate 40/min or Spo2 90 despite max FiO2, worsening hypercapnia, deterioration of GCS 12, severe hemodynamic instability.

研究概览

简要总结

Oxygen delivered through HFNC  has been successfully used in several settings. However the indications are not absolute with much of the prove and benefit being subject and physiologic most data to support it are derived from observational studies using physiological outcomes or from randomised trial studying heterogeneous population. As hfnc is non invasive and may benefit in overall mortality prevention in patients with respiratory failure, a proper scoring is lacking to predict the success of its application and preventing the escalation of therapy. The ROX index may help guidelines in this regard. The main aim of the study is to compare ROX index versus HACOR scale in predicting hfnc success in acute hypoxemic respiratory failure. At 1,2 and 6 hours after hfnc initiation two parameters will be assessed for the utility in predicting hfnc success.

Hacor scale consists of five components with weighted score points the components are pulse rate (0-1), ph(0-4), GCS (0-10),PaO2/Fio2 (0-6) and respiratory rate(0-4).

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patient presenting with acute hypoxemic respiratory failure (room air spo2 equal to less than 90% or PaO2 less than 60 mmhg).
  • The need for oxygen supplemental via face mask greater than 9 L/min to maintain spo2 greater than 92%.

排除标准

  • Requiring immediate mechanical ventilation Cardiopulmonary arrest Pneumothorax Severe respiratory acidosis or suspected hypercapnic respiratory failure.
  • Hemodynamic instability with MAP less than 65mmhg.

结局指标

主要结局

Primary outcome was defined as no intolerance requiring hfnc removal and no escalation to invasive or non invasive ventilation within 48 hours after hfnc application i.e HFNC will be terminated if any of the following criteria for termination is met adopted from British thoracic guidelines; respiratory rate 40/min or Spo2 90 despite max FiO2, worsening hypercapnia, deterioration of GCS 12, severe hemodynamic instability.

时间窗: After applying HFNC, respiratory rate oxygenation (ROX) and HACOR(The HACOR score is based on five components: heart rate, acidosis, consciousness, oxygenation, and respiratory rate) score will be calculated at 1,2 and 6 hours after first application of HFNC. Patient will be observed for 48 hours to see if there is escalation of oxygenation support in the form of ventilator(invasive or non invasive)

次要结局

  • To compare individual components of the scoring index(Individual components of scoring (heart rate, respiratory rate & SpO2) will be assessed at 1,2 & 6 hours after application of HFNC.)

研究者

发起方
VMMC and SAFDARJUNG HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Tejawat Kushal Kumar

Vardhaman mahavir medical College and Safdarjung hospital

研究点 (1)

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