Use of High Flows in Pediatric Cardiac Surgical Patients
Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients
Humidified high flow nasal prong oxygen therapy is a method for providing oxygen and CPAP. The delivery of high flows decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase. In addition, a flow-dependent effect of continuous positive airway pressure, possibly due to an air entrainment mechanism, has been documented in healthy volunteers and in patients with COPD.
The investigators working hypothesis is that the use of post-extubation CPAP delivered via nasal cannulae in infants less than 18 months, post-bypass surgery will have better PaCO2 values than infants extubated on to oxygen therapy.
研究概览
详细说明
After CICU admission, infants with no bleeding, normothermic and hemodynamically stable will be switched from PRVC to SIMV+PSV (10-15cmH20) which should be maintained for 4 hours. An arterial gas analysis will be performed after 20 minutes. Infants with normal gas-exchange are gradually weaned from mechanical ventilation At each weaning step an arterial hemogasanalysis is performed after 20 minutes, to assess if the decreased ventilatory support is tolerated. Increased work of breathing and respiratory acidosis (ph< 7.3 or pCO2 > 60 mmHg) are considered criteria to withhold the weaning process. After a 4 hour period on SIMV+PSV the child should be switched to PSV for 30 minutes and then extubated. The following extubation criteria should be reached:
- Satisfactory blood gases with PCO2 under 45mmHg, pH greater than 7.30.
- Fractional inspired oxygen concentration of 65% and or less than the baseline value
- Adequate respiratory frequency according to age without dyspnea
At this point criteria for extubation are reached. Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Rome、意大利、00165
- 招聘中
- Ospedale Bambino Gesù
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接触：
- Francesca G Iodice, M.D.
- 电话号码：2449 0039066859
- 邮箱：francesca_iodice@yahoo.it
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首席研究员：
- Francesca Iodice, M.D.
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Rome、意大利、00195
- 招聘中
- Francesca Iodice
-
接触：
- Francesca Iodice, MD
- 电话号码：393336545045
- 邮箱：fgiovanna.iodice@opbg.net
-
接触：
- Francesca Iodice
- 电话号码：393336545045
- 邮箱：francesca_iodice@yahoo.it
-
副研究员：
- Giuseppina Testa, MD
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副研究员：
- Vincenzo Vitale, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age: 0-18 months
- Mechanical Ventilation via an endotracheal tube
- Elective surgery
- Post-bypass procedure
- Rachs 2 and above
Exclusion Criteria:
- Presence of major congenital malformations
- Presence of neuromuscular disease
- Presence of non drained pneumothorax
- Absent respiratory drive or recurrent apneas
- Hemodynamic instability
- Glasgow coma score (GCS) less than 8
- ECG with evidence of ischaemia or arrhythmias
- Active bleeding
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：High flows
|
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
其他名称：
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
其他名称：
|
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其他：oxygen therapy
|
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The primary aim of this study is to show an improvement of the average levels of postextubation PaCO2 in infants less than 18 months of age and post-bypass surgery
大体时间：Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The secondary aim is to verify the reintubation rate between the two groups.
大体时间：Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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Other points that will be evaluated are: the improvement of X-ray findings, the length of ICU stay and the development of complications such as nasal ulcers and gastric distension.
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Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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合作者和调查者
调查人员
- 首席研究员：Francesca Iodice, MD、Ospedale Bambino Gesu'
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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