Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation (HiFiPPS)
2018年7月20日 更新者：Daniel Klotz、University of Freiburg
Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation: A Randomized Controlled Pilot Trial
Procedural sedation is an established and safe intervention and is widely used in diagnostic and therapeutic procedures for pediatric patients.
Nonetheless, problems of the respiratory system such as upper airway obstruction, hypoventilation and apnea are frequent adverse events.
We postulate that respiratory instability is less frequent in patients high flow nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in pediatric procedural sedation.
The purpose of this pilot study is to estimate the effect of HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper gastrointestinal endoscopy under pediatric procedural sedation (PPS).
研究概览
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Freiburg、德国、79100
- Center for Pediatrics, Pediatric Intensive Care Unit, Procedure Room, Medical Center - University of Freiburg
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 6 years - 18 years
- Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation
- Informed consent/assent for enrollment by parents/legal guardians/patient
Exclusion Criteria:
- Congenital or acquired malformations involving the airways
- Patients with the history of spontaneous pneumothorax or connectives tissue diseases (Marfan syndrome, Ehlers-Danlos-Syndrome)
- Patients with a history of traumatic/iatrogenic air leak within the last 3 months before enrollment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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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有源比较器：Standard care
Standard respiratory care.
Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
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Standard respiratory care.
Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
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实验性的：High Flow nasal cannula
Application of humidified heated ambient air with flow rates adapted to body weight of respective subject.
Incremental increase of fraction of inspired oxygen as appropriate to maintain oxygenation (defined as transcutaneous pulse oximetry above 93%).
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Application of humidified heated ambient air with flow rates adapted to body weight of respective subject.
Incremental increase of fraction of inspired oxygen as appropriate to maintain oxygenation (defined as transcutaneous pulse oximetry above 93%).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Respiratory instability
大体时间：Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Number of episodes longer than 15 seconds with SpO2 < 93% and/ or pCO2 > 45 mmHg and/ or apnea (defined as cessation of airflow for > 15 seconds)
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Time frame from first applications of intravenous sedatives until finishing the intended procedure
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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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Duration of respiratory instability
大体时间：Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Total duration of episodes longer than 15 seconds with oxygenation as measured per pulse oximetry < 93% and/or transcutaneously measured carbon dioxide partial pressure > 45 mmHg and/ or apnea (defined as cessation of airflow for > 15 seconds)
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Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Number of interventions to regain respiratory stability
大体时间：Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Number of interventions to reestablish respiratory stability (combined numbers of episode for jaw thrust, repositioning of the patient, repositioning of the patients head, tactile stimulation)
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Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Need for noninvasive ventilation
大体时间：Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Number of episodes of bag-mask-ventilation
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Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Time of procedure in minutes
大体时间：Duration of the procedure for which sedation is determined. It covers the time period from first positioning of the patient to repositioning of the patient or patients extremities after completion of the procedure
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Time of procedure in minutes
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Duration of the procedure for which sedation is determined. It covers the time period from first positioning of the patient to repositioning of the patient or patients extremities after completion of the procedure
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Time of sedation in minutes
大体时间：Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Time of sedation in minutes
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Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Use of sedatives
大体时间：Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Cumulative dose of i.v.
sedatives in mg/kg bodyweight/min of procedure
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Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Use of analgesics
大体时间：Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Cumulative dose of i.v.
analgesics in µg/kg bodyweight/min of procedure
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Time frame from first applications of intravenous sedatives until finishing the intended procedure
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Nausea and vomiting
大体时间：24 hours after procedural sedation
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Number of Episodes with nausea and/or vomiting within 24 hours after procedural sedation
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24 hours after procedural sedation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Daniel Klotz, M.D.、Center for Pediatrics, Dep. of Pediatric Intensive Care, Medical Center - University of Freiburg, Freiburg, Germany
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Deitch K, Chudnofsky CR, Dominici P. The utility of supplemental oxygen during emergency department procedural sedation and analgesia with midazolam and fentanyl: a randomized, controlled trial. Ann Emerg Med. 2007 Jan;49(1):1-8. doi: 10.1016/j.annemergmed.2006.06.013. Epub 2006 Sep 15.
- Deitch K, Chudnofsky CR, Dominici P, Latta D, Salamanca Y. The utility of high-flow oxygen during emergency department procedural sedation and analgesia with propofol: a randomized, controlled trial. Ann Emerg Med. 2011 Oct;58(4):360-364.e3. doi: 10.1016/j.annemergmed.2011.05.018. Epub 2011 Jun 15.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年9月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月19日
研究注册日期
首次提交
2016年10月9日
首先提交符合 QC 标准的
2016年10月11日
首次发布 (估计)
2016年10月12日
研究记录更新
最后更新发布 (实际的)
2018年7月24日
上次提交的符合 QC 标准的更新
2018年7月20日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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