Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion
Even if the laryngeal mask (LM) is considered a very safe device with a low incidence of complications there may be situations where it is difficult to insert.
Therefore it seems appropriate to carry out a prospective observational study that will identify the risk factors relating to the positioning of LM for the purpose of identification and prediction of them.
From reading the literature and from the opinion of the experts with extensive practice in airway management (part of the Working Group "Management of Airway" of the Italian Society of Anaesthesia, Analgesia, Resuscitation and Intensive Care) some possible causes of difficulty in the insertion of laryngeal mask have been identified; these possible causes were listed in a report that will be distributed to the centers enrolled in the conduction of the study.
1,864 patients will be enrolled in 8 Italian research centers to calculate the relative risk of each of the factors analyzed in order to identify those that, in view of the LM positioning, must be modified to reduce the risk of failure and, secondly, to identify the risk factors whose presence may contraindicate the use of the device and indicate the use of alternative methods for airway management.
研究概览
详细说明
Backgrounds Since its introduction into clinical practice in 1983, the laryngeal mask (LM) has found a role in the daily practice of anesthesiologists, including its use as a primary device in the airway management in both elective and emergency and as an emergency approach to the management of difficult airways.
Moreover, the insertion of the LM has become a common technique in the management of the airway, in particular outpatient surgery, where it is associated with a shorter recovery time, faster discharge and thus with a reduction of costs.
Even if the LM is considered a device very safe with a low incidence of complications, there may be situations where it is difficult to insert.
Aim of the study Some studies have concerned the causes that determine the difficulty in the insertion of an LM. They are retrospective studies and/or focused on the analysis of a single type of device.
Therefore, it seems appropriate to carry out a prospective observational study that will identify and weight the risk factors relating to the positioning of LM for the purpose of identification and prediction of them.
Methods From reading the literature and from the opinion of the experts with extensive practice in airway management (part of the Working Group "Management of Airway" of the Italian Society of Anaesthesia, Analgesia, Resuscitation and Intensive Care SIAARTI) some possible causes of difficulty in the insertion of laryngeal mask have been identified; these possible causes were listed in a report that will be distributed to the centers enrolled in the conduction of the study.
The centers will be selected based on the fact that between the researchers is including an anesthesiologist part of the Working Group "Airway management" of SIAARTI to act as supervisor.
Statistic Descriptive: for each quantitative variable will be reported mean, standard deviation, first and third quartiles, median, minimum and maximum. For each qualitative variable will be reported frequency and percentage of each category.
Explorative: The association between each risk factor and the proportion of incorrect insertion will be evaluated only in a univariate analysis, using the relative risk and its confidence interval.
Sample size: For a hypothesis test on the relative risk so specified H0: RR ≤ 1 H1: RR> 1 and considering an expected relative risk of 2, a proportion of 2.9% of the failures in the group of experts and a first type error equal to 5%, 832 patients per group are needed to ensure a power equal to 90%.
The limit of significance is set at 5%.
Expected results To calculate the relative risk of each of the factors analyzed in order to identify those that, in view of the LM positioning, can be modified to reduce the risk of failure and, secondly, to identify the risk factors whose presence may contraindicate the use of the device and indicate the use of alternative methods for airway management.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Firenze、意大利、50136
- Alessandro Di Filippo
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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
取样方法
研究人群
描述
Inclusion Criteria:
- ASA classification I-II
- Age between 18 and 65 years
- Airway management with laryngeal mask
- Signed informed consent to the study in the medical record
Exclusion Criteria:
- Diseases of the upper airways
- Risk of inhalation of gastric contents (previous gastric surgery, hiatal hernia, gastroesophageal reflux, peptic ulcer, stomach full, pregnancy)
- Large obese (BMI> 40)
- Sore throat, voice alteration
- A history of difficult intubation
- Intervention lasting more than 4 hours
学习计划
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 |
---|---|
easy Laryngeal Mask insertion
patients in whom the insertion of the SIM has proven easy
|
airway management with laryngeal mask
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difficult Laryngeal Mask insertion
patients in whom the insertion of the SIM has proven difficult
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airway management with laryngeal mask
|
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 |
---|---|---|
Success in the first attempt
大体时间:Immediately after the attempt of insertion
|
number
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Immediately after the attempt of insertion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Need for 2 or more attempts
大体时间:Immediately after the attempt of insertion
|
number
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Immediately after the attempt of insertion
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Substitution with another LM of different size
大体时间:Immediately after the attempt of insertion
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number
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Immediately after the attempt of insertion
|
Change in strategy (intubation, awakening)
大体时间:Immediately after the attempt of insertion
|
number
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Immediately after the attempt of insertion
|
Ventilation difficulties
大体时间:Immediately after the attempt of insertion
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number
|
Immediately after the attempt of insertion
|
Movement or swallowing after placement
大体时间:Immediately after the attempt of insertion
|
number
|
Immediately after the attempt of insertion
|
合作者和调查者
调查人员
- 首席研究员:Alessandro Di Filippo, Dr、Azienda Ospedaliero-Universitaria Careggi
出版物和有用的链接
一般刊物
- Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and nonconventional usage. Anesth Analg. 1996 Jan;82(1):129-33. doi: 10.1097/00000539-199601000-00023.
- Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
- Apfelbaum JL, Walawander CA, Grasela TH, Wise P, McLeskey C, Roizen MF, Wetchler BV, Korttila K. Eliminating intensive postoperative care in same-day surgery patients using short-acting anesthetics. Anesthesiology. 2002 Jul;97(1):66-74. doi: 10.1097/00000542-200207000-00010.
- Katsiampoura AD, Killoran PV, Corso RM, Cai C, Hagberg CA, Cattano D. Laryngeal mask placement in a teaching institution: analysis of difficult placements. F1000Res. 2015 Apr 29;4:102. doi: 10.12688/f1000research.6415.1. eCollection 2015.
- Brimacombe J. The advantages of the LMA over the tracheal tube or facemask: a meta-analysis. Can J Anaesth. 1995 Nov;42(11):1017-23. doi: 10.1007/BF03011075.
- Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. doi: 10.1093/bja/55.8.801.
- White PF. Ambulatory anesthesia advances into the new millennium. Anesth Analg. 2000 May;90(5):1234-5. doi: 10.1097/00000539-200005000-00047. No abstract available.
- Suhitharan T, Teoh WH. Use of extraglottic airways in patients undergoing ambulatory laparoscopic surgery without the need for tracheal intubation. Saudi J Anaesth. 2013 Oct;7(4):436-41. doi: 10.4103/1658-354X.121081.
- Berlac P, Hyldmo PK, Kongstad P, Kurola J, Nakstad AR, Sandberg M; Scandinavian Society for Anesthesiology and Intensive Care Medicine. Pre-hospital airway management: guidelines from a task force from the Scandinavian Society for Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2008 Aug;52(7):897-907. doi: 10.1111/j.1399-6576.2008.01673.x.
- Lubarsky DA. Fast track in the postanesthesia care unit: unlimited possibilities? J Clin Anesth. 1996 May;8(3 Suppl):70S-72S. doi: 10.1016/s0952-8180(96)90016-1. No abstract available.
- Buckham M, Brooker M, Brimacombe J, Keller C. A comparison of the reinforced and standard laryngeal mask airway: ease of insertion and the influence of head and neck position on oropharyngeal leak pressure and intracuff pressure. Anaesth Intensive Care. 1999 Dec;27(6):628-31. doi: 10.1177/0310057X9902700612.
- Ramachandran SK, Mathis MR, Tremper KK, Shanks AM, Kheterpal S. Predictors and clinical outcomes from failed Laryngeal Mask Airway Unique: a study of 15,795 patients. Anesthesiology. 2012 Jun;116(6):1217-26. doi: 10.1097/ALN.0b013e318255e6ab.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
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laryngeal mask insertion的临床试验
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Northern Health and Social Care TrustAntrim Area Hospital完全的