High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- the rate of"escalation of care due to treatment failure" within 72 hours after extubation
研究概览
简要总结
High flow nasal cannula(HFNC) ventilation can provide such effects as wash-out effect of the carbon dioxide inside the anatomical dead space,some level of continuous airway pressure and humidified oxygen gases.
Therefore because of its physiological benefits, it has been reported that HFNC can reduce "treatment failure" after extubation in pediatric patients like preterm babies,or infants who suffer from bronchitis.
However there is no evidence showing that HFNC can reduce "treatment failure" after extubation in pediatric patients after cardiothoracic surgery.
This multi-center randomized controlled trial (RCT) involving pediatric patients after cardiothoracic surgery will be conducted to determine whether HFNC,compared with conventional oxygen therapy,after extubation can reduce the rate of"escalation of care due to treatment failure".
详细描述
The multi-center RCT will enroll 380 pediatric patients after cardiothoracic surgery from the Intensive Care Units (ICUs) in Japan.Informed consent will be obtained from the their parents or legally representatives.They will receive postoperative standard care in ICU and spontaneous breathing test(SBT).If SBT will be done successfully,they will be extubated.Just before extubation,they will be divided randomly into the intervention group or the control group.After randomization,they will be extubated.After extubation,the intervention group will receive HFNC therapy,while the control group will receive conventional oxygen therapy.The flow in the intervention group will surely be maintained to be high,while the flow in control group will surely be less than 2 liter/min.In both groups,outcome measure will be assessed within 72 hours after extubation,or during ICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single blind .Participants and their legal representatives are blinded.
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients younger than two years old after cardiothoracic surgery
- •pediatric patients who have been ventilated for more than 12 hours after surgery
排除标准
- •patients with tracheostomy
- •patients with do-not-resuscitate (DNR)
- •patients who have be treated by noninvasive positive pressure ventilation or high flow nasal cannula before surgery
- •patients who undergo unplanned extubation
- •patients who have withdrawn consent from their legal guardian
- •patients who don't need oxygen therapy
- •patients who are planned to receive treatment with noninvasive positive pressure ventilation after extubation
- •patients who are planned to inhale nitric oxide(NO) after extubation
结局指标
主要结局
the rate of"escalation of care due to treatment failure" within 72 hours after extubation
时间窗: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
次要结局
- adverse events(through study completion,an average of 1 month)
- arterial blood gas(Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.)
- non event rate within 72 hours after extubation(Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.)
- peripheral oxygen saturation(Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.)
- Catecholamine score(Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.)
- Oxygen flow rate(Outcome is assessed at the time as follows;1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.)
- fractional inspired oxygen(Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.)
- sedative dose(Outcome is assessed like as follows;total dose from 6 hours before extubation to extubation,total dose from 18 hours to 24 hours after extubation,total dose from 42 hours to 48 hours after extubation,total dose from 66 hours to 72 hours after extubation.)
- Chest x-ray score(Outcome is assessed within 24 hours before extubation,within 24 hours after extubation.)
- criteria of "treatment failure"(Outcome measure is assessed within 72 hours after extubation.)
- Details of"escalation of care"(Outcome measure is assessed within 72 hours after extubation.)
- at the time of 72 hours after extubation, treatment outcome of the patients who have been diagnosed as "treatment failure"(Outcome measure is assessed at the time of 72 hours after extubation)
- the rate of reintubation at the time of 72 hours after extubation(Outcome measure is assessed at the time of 72 hours after extubation)
- the length of ICU stay(through study completion,an average of 1 month)
- the length of hospital stay(Outcome measure is assessed when the patients is discharged from the hospital or the time of six months after extubation.)
- vital sign(Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.)
- prespecified sub group analysis(Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.)