Effect of two different flow rates with high flow nasal cannula on respiratory parameters in patients with acute hypoxemic respiratory failure:Prospective randomised cross-overstudy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare change in PO2,PCO2 and PaO2/FiO2 at the flow rates of 60 litres/minute and 30 litres/minute.
研究概览
简要总结
When using High Flow Nasal Cannula (HFNC), it is important to consider the flow settings, as they have a significant impact on the therapy’s physiological effects.The effect of different oxygen flow rates by HFNC on respiratory physiology has not been adequately studied.We plan this study to compare the clinical response (vitals and arterial blood gas parameters) on two different flows (30 Litres/Minute and 60 Litres/Minute ) of HFNC therapy in patients with acute hypoxemic respiratory failure with a PaO2/FiO2 < 300.Our hypothesis is that there is no difference in arterial blood gas and respiratory parameters at all point intervals between the HFNC flow rates 60 Litres/Minute and 30 Litres/Minute.
Patients admitted in adult intensive care unit in AIIMS, Jodhpur with Acute hypoxemic respiratory failure who are on HFNC and hemodynamically stable with PaO2/FiO2 ratio less than 300 will be selected for the study. The study participants will be recruited after approval from the Institutional Ethics Committee and registration with the Clinical Trials Registry of India(CTRI). Patients will be randomly assigned with a 1:1 ratio to HFNC 60 group (HFNC flow at 60L/min initially for 1hour followed by 30L/min for next 1 hour)and HFNC 30 group (HFNC flow at 30L/min initially for 1 hour followed by 60L/min for next 1 hour) with FiO2 adjusted to maintain SPO2 >94%.The patients will be observed for one hour and at the end of one hour the study parameters -PCO2 ,PO2, PaO2/FiO2, ROX index , Respiratory Rate, Heart Rate and Mean Arterial Pressure will be recorded .After that the flow will be changed to 30L/min in HFNC 60 group and 60L/min in HFNC 30 group and patients will be again observed for one hour. At the end of one hour again the same parameters will be recorded. The change in study parameters will be compared in both the groups. Subsequent treatment will be decided by the attending clinician.
The intervention will be labelled as a failure if fall in saturation below 92%, respiratory distress (RR >35) or hemodynamic instability (Fall in MAP of 5% or more) occur during the one hour observation period. The further management of the patient will be done as per the ICU protocol by the treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All hemodynamically stable patients admitted in Adult Intensive Care Unit in AIIMS,Jodhpur with acute hypoxemic respiratory failure,on High Flow Nasal Cannula with PaO2/FiO2 less than 300 are included in the study.
排除标准
- •Patients with hypoxemic respiratory failure requiring intubation and ventillatory support as per the attending clinician.
- •Patients of chronic respiratory failure.
- •Patients with neuromuscular disorders affecting respiratory muscles and/or diaphragm.
- •Patients with major cardiac, hepatic or renal functions derangement.
- •Pregnant patients.
- •Tracheostomised patients.
- •All the conditions where HFNC is contraindicated like upper airway obstruction, central apnoea, blocked nasal passages or choanal atresia, trauma or surgery to nasopharynx , pneumothorax etc.
结局指标
主要结局
To compare change in PO2,PCO2 and PaO2/FiO2 at the flow rates of 60 litres/minute and 30 litres/minute.
时间窗: After 1 hour of changing HFNC oxygen flow rate.
次要结局
- 1)To compare incidence of desaturation requiring increase in FiO2.(2)To compare change in ROX index.)
研究者
Dr Lekshmi S
All India Institute of Medical Sciences ,Jodhpur.