The Safety and Efficacy of Supraglottic Airway Use in Children
2015年7月27日 更新者：Narasimhan Jagannathan、Ann & Robert H Lurie Children's Hospital of Chicago
This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.
研究概览
详细说明
This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.
Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.
The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.
研究类型
观察性的
注册 (预期的)
10000
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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Illinois
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Chicago、Illinois、美国、60611
- 招聘中
- Ann & Robert H. Lurie Children's Hospital of Chicago
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接触：
- Narasimhan Jagannathan, MD
- 邮箱：simjag2000@yahoo.com
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首席研究员：
- Narasimhan Jagannathan, MD
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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
1天 至 18年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Pediatric patients undergoing anesthesia with use of a supraglottic airway device as primary means of oxygenation and ventilation.
描述
Inclusion Criteria:
- Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation & ventilation
Exclusion Criteria:
- N/A
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Supraglottic Airway Device
Patients will receive a supraglottic airway device as a primary means of ventilation.
The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device.
Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines
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其他名称：
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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 |
|---|---|---|
|
Supraglottic Airway Device Failure
大体时间：participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ease of Placement of Supraglottic Airway Device
大体时间：participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Multiple Attempts to Place Supraglottic Airway Device
大体时间：participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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change in device, placement method, and provider will be recorded
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
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Airway Maneuvers/interventions
大体时间：participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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the number and type of airway maneuvers performed after device placement and during maintenance will be recorded
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
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Occurrence of Inadequate Ventilation
大体时间：participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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cause and solution for inadequate ventilation will be recorded
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
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Intraoperative Complications
大体时间：participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie.
dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded
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participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Postoperative Complications
大体时间：participants will be followed for the duration of anesthesia and 24 hours postoperatively
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Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness
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participants will be followed for the duration of anesthesia and 24 hours postoperatively
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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：Narasimhan Jagannathan, MD、Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
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
- Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.
- Mathis MR, Haydar B, Taylor EL, Morris M, Malviya SV, Christensen RE, Ramachandran SK, Kheterpal S. Failure of the Laryngeal Mask Airway Unique and Classic in the pediatric surgical patient: a study of clinical predictors and outcomes. Anesthesiology. 2013 Dec;119(6):1284-95. doi: 10.1097/ALN.0000000000000015.
- Jagannathan N, Sequera-Ramos L, Sohn L, Wallis B, Shertzer A, Schaldenbrand K. Elective use of supraglottic airway devices for primary airway management in children with difficult airways. Br J Anaesth. 2014 Apr;112(4):742-8. doi: 10.1093/bja/aet411. Epub 2013 Dec 8.
- Asai T. Is it safe to use supraglottic airway in children with difficult airways? Br J Anaesth. 2014 Apr;112(4):620-2. doi: 10.1093/bja/aeu005. Epub 2014 Feb 20. No abstract available.
- Bordet F, Allaouchiche B, Lansiaux S, Combet S, Pouyau A, Taylor P, Bonnard C, Chassard D. Risk factors for airway complications during general anaesthesia in paediatric patients. Paediatr Anaesth. 2002 Nov;12(9):762-9. doi: 10.1046/j.1460-9592.2002.00987.x.
- Lalwani K, Richins S, Aliason I, Milczuk H, Fu R. The laryngeal mask airway for pediatric adenotonsillectomy: predictors of failure and complications. Int J Pediatr Otorhinolaryngol. 2013 Jan;77(1):25-8. doi: 10.1016/j.ijporl.2012.09.021. Epub 2012 Oct 11.
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
2014年6月1日
初级完成 (预期的)
2015年10月1日
研究完成 (预期的)
2015年10月1日
研究注册日期
首次提交
2014年7月25日
首先提交符合 QC 标准的
2014年7月25日
首次发布 (估计)
2014年7月28日
研究记录更新
最后更新发布 (估计)
2015年7月29日
上次提交的符合 QC 标准的更新
2015年7月27日
最后验证
2015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.