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临床试验/CTRI/2024/01/062156
CTRI/2024/01/062156招募中3 期

Effect of Adaptive Support Ventilation when compared with Conventional Ventilation in mechanically ventilated children – A Randomized Control Trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月3日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
100
试验地点
1
主要终点
Duration of ventilation

研究概览

简要总结

Soon after admission to Pediatric Intensive Care unit, Department of Pediatrics, AIIMS, Raipur, the patient will undergo screening for enrollment based on inclusion & exclusion criteria. If the patient doesn’t meet the inclusion criteria, he/she will be excluded. After inclusion into the study informed consent will be obtained from the patient’s legal guardian. Once consent is obtained patient will be randomized using computer generated block randomization with concealed allocation. The primary details and the disease status of the patient will be recorded in both the groups. Patient in the intervention group will undergo adaptive support ventilation using Hamilton G5 ventilator. The patient will be monitored for synchrony of ventilation and improvement in oxygenation and carbon dioxide, then P/F ratio, oxygenation index, lung stress index. The tidal volume and RR generated by the ASV mode will be documented.  The time taken to achieve synchronous ventilation will be documented. In control group, the conventional ventilation therapy according to unit’s protocol will be followed. Patient will be monitored in both intervention and control group and when the patient is not able to maintain either ventilation or oxygenation in any group, we would opt to transfer them to rescue mode of ventilation which is HFOV or APRV mode. The primary and secondary outcome will be recorded and followed up until discharge or death or for the next 28 days whichever is earlier in both the groups. Then data recorded will be analyzed using SPSS latest version.

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 15.00 Year(s)(—)
性别
All

入选标准

  • Children from 1 month to ≤15 years of age with acute need for invasive mechanical ventilation inclusive of acute respiratory illness, congenital heart disease, post cardiac surgery, acute neurological diseases and multi-organ dysfunction by oral endotracheal tube.

排除标准

  • Expected death within 24 hours of intubation Refusal to consent.

结局指标

主要结局

Duration of ventilation

时间窗: Till 28 days from the date of enrollment

次要结局

  • Extubation failure(Length of PICU stay)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Abinaya Kannan

All India Institute of Medical Sciences

研究点 (1)

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