跳至主要内容
临床试验/CTRI/2025/12/099718
CTRI/2025/12/099718尚未招募2/3 期

Evaluation Of Clinical Outcomes Using A Nebuliser-Cum-Oxygen Mask In Pediatric Respiratory Distress

Saveetha medical college hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月9日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1

研究概览

简要总结

Children presenting with respiratory distress frequently require both oxygen therapy and nebulization. In routine practice, these interventions are delivered using separate devices, which may lead to interruption of oxygen delivery, increased treatment time, and logistical challenges, particularly in emergency settings.This randomized, double-blinded, parallel-group controlled trial aims to evaluate the clinical outcomes of an integrated nebuliser-cum-oxygen mask compared to conventional sequential oxygen and nebulization therapy in pediatric patients with mild to moderate respiratory distress. A total of 150 children aged 1 month to 12 years attending the Department of Paediatrics at Saveetha Medical College and Hospital will be enrolled and randomly allocated to either the intervention group or the control group.The primary outcomes include time to symptom relief, stability of oxygen saturation during therapy, and overall recovery time. Secondary outcomes will assess cost-effectiveness, user satisfaction, and the incidence of adverse events. By combining two essential respiratory interventions into a single, low-cost, and easy-to-use device, this study seeks to improve treatment efficiency, enhance patient safety, and reduce healthcare burden, particularly in emergency and resource-limited pediatric care settings.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children aged 1 month to 12 years presenting with mild to moderate respiratory distress, requiring both oxygen therapy and nebulization, whose parents or legal guardians provide written informed consent.

排除标准

  • Children with severe respiratory distress requiring immediate ventilatory support, congenital airway anomalies, chronic lung disease, known hypersensitivity to nebulized medications, or those already on advanced respiratory support.

研究者

发起方
Saveetha medical college hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Dinesh kumar

Saveetha medical college hospital

研究点 (1)

Loading locations...

相似试验