跳至主要内容
临床试验/CTRI/2024/07/069786
CTRI/2024/07/069786尚未招募不适用

Efficacy of high flow nasal cannula versus indigenous bubble continuous positive airway pressure & conventional oxygen through nasal cannula in moderate bronchiolitis A Randomized controlled trial

Pradeep Reddy V1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2024年7月15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
129
试验地点
1
主要终点
Time to wean off oxygen (hrs)

研究概览

简要总结

This randomized controlled open lable study will be conducted in the Department of Paediatrics, Sri Manakula Vinayagar Medical College And Hospital(SMVMCH) a tertiary care hospital in Puducherry after the approval of Research Committee and Institutional Ethics Committee .Any infant  from 1month to 24 months age, who fulfill the inclusion and exclusion criteria will be included in the study after the informed and written consent is being obtained from parents.

 Sequential number, sealed opaque envelope will be opened by the post graduate , the child will be allotted to respective intervention group as per the block randomized list. Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

 The participants clinical condition and intervention will be explained to the parents and mode of oxygen delivery will be assigned for (Group A - HFNC)  (Group B – Indigenous bubble CPAP) and  (Group C – Nasal prongs). They are assessed at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Infants with HFNC group will be delivered Humidified Oxygen  using Fisher and Paykal HFNC machine. Children allotted into indigenous bubble CPAP group will be delivered oxygen  using Chest drainage bottle 500ml with Nasal prongs, Children allotted into prongs group will be delivered oxygen using appropriate size Nasal prong cannula system connected directly.

 Time for resolution of underlying condition will be sequentially monitored in HFNC, indigenous bubble CPAP and prongs group and will be entered.

 Children labeled to have treatment failure if they have :

•         Hypoxia

•         Fio2> 60%

•         Retractions persists

•         Developing shock requiring inotrope support

Cross over is possible from Group A to Group C if response is  adequate. At serial reassessment if response is not adequate in group B or C, cross over will be done to group A. In worsening of symptoms and non-responders, Escalation of treatment will be proceeded to  Invasive ventilation or mechanical ventilation.

Nasal trauma will be classified at the point of  removal .

Compliance of nasal prongs, indigenous bubble CPAP and HFNC is being measured by using number of instances readjustment needed by every 2nd hourly monitoring the position of HFNC and prongs for respective group of patients.

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
1.00 Month(s) 至 24.00 Month(s)(—)
性别
All

入选标准

  • One month to 24 month old child Moderate bronchiolitis.

排除标准

  • Parents of children who refused to give consent.
  • Referred patients who already received HFNC outside in other hospitals and referred with complications of it.
  • Those with added cardiac illness Anatomical abnormalities of respiratory tract Moderate bronchiolitis Other respiratory illnesses like pneumonia, pleural effusion, pyothorax.

结局指标

主要结局

Time to wean off oxygen (hrs)

时间窗: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Primary treatment duration (hrs)

时间窗: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Instances of requirement of readjustments

时间窗: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Grade of nasal soft tissue injury

时间窗: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

Primary treatment failure

时间窗: Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.

次要结局

  • Picu length of stay (days)(Hospital length of stay (days))

研究者

发起方
Pradeep Reddy V
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Pradeep Reddy V

sri manakula vinayagar medical collage and hospital

研究点 (1)

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