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临床试验/NCT01288248
NCT01288248Unknown3 期

The Risk of Laryngospasm in Children is Similar to the Use of the Laryngeal Mask and the Endotracheal Tube in Children 2 Years to 14 Years: Clinical Trial Randomized Noninferiority

Universidad de Antioquia2 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
338
试验地点
2
主要终点
Laryngospasm clinically manifested as inspiratory stridor and/or expiratory, no breath sounds, paradoxical movement of the thorax and abdomen and desaturation, bradycardia, central cyanosis.

研究概览

简要总结

The purpose of this study is to determine whether the use of laryngeal mask classic as method for securing the airway in the population of 2 years to 14 years is associated with risk of laryngospasm as compared with the use of endotracheal tube.

详细描述

Laryngospasm, defined as closure of the glottis as a protective reflex secondary to abnormal stimulation (7), with a reported incidence in the general population of 8.7 per 1000 patients undergoing surgical procedures (8), is considered the most common event among the complications in the management of pediatric airway, causing 40% of obstructive events after extubation (7-8), with incidents reported in the American pediatric population from 0.4% to 14% (8-9) for population under 6 years and 3.6% in > 6 years. Among the risk factors associated with the development of laryngospasm and anesthesia in children are: age, ASA (4), upper respiratory infection (10), among others, however in recent years has gained interest and generated dispute the association between this outcome and the type of device used to secure the airway during anesthesia. Although the endotracheal tube device is considered the "gold standard" for airway management, this has been associated with an increased incidence of laryngospasm (8), explained this phenomenon, apparently by direct stimulation because the tube into the larynx and trachea, which triggers, in theory, a posterior laryngeal reflex intense (11).

In recent years, with the advent of new devices for securing the airway, especially supraglottic use type Classic Laryngeal Mask (LM), it was thought that the main trigger of laryngospasm, laryngeal and tracheal stimulation caused by the endotracheal tube (ETT), would be resolved and will decrease the incidence of complications in the pediatric population; however, three recent prospective studies (10-11-12) is no statistically significant difference in incidence of laryngospasm among laryngeal mask and endotracheal tube. By contrast, two retrospective studies (6.4) have shown increased incidence of laryngospasm compared to ETT in children. In 2002, one of the aforementioned prospective studies (11), found an incidence of laryngospasm 11.2% versus 16.9% for ETT versus ML, respectively, but without an increase in relative risk statistically significant when comparing the ML to ETT.

In view of these findings and considering that most studies in this respect seem to have technical and methodological limitations, our objective is to determine by controlled clinical trial non inferiority the risk of laryngospasm with the endotracheal tube vs a device supraglottic, Classic Laryngeal Mask type as a method of airway patency in the pediatric population, assuming that the risk of laryngospasm with both devices is equal.

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 (Outcomes Assessor)

入排标准

年龄范围
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I and III children, 1-14 years of age
  • Children scheduled for surgery or therapeutic procedures under general anesthesia and fasting as defined in the fasting guidelines
  • Responsible adult patients whose accept and sign the informed consent of study

排除标准

  • Surgery of the head, neck, chest and/or abdomen (except the abdominal wall)
  • Position different than the supine in surgery
  • Malformations or anatomic abnormalities of the face and airway
  • Procedures over 3 hours
  • Patients with pulmonary aspiration risk: morbid obesity, intestinal obstruction, gastrointestinal bleeding, gastroparesis, gastroesophageal reflux
  • Patients with limited mouth opening or cervical spine extension and classified as difficult airway

结局指标

主要结局

Laryngospasm clinically manifested as inspiratory stridor and/or expiratory, no breath sounds, paradoxical movement of the thorax and abdomen and desaturation, bradycardia, central cyanosis.

时间窗: The appearance of the outcome will be measured from anesthetic induction until the patient is fully awake

It should be noted that once the subject of study presents the primary outcome may end up changing the device to improve ventilation.

次要结局

  • Desaturation defined as SaO2 < 90% in pulse oximetry associated with laryngospasm(from anesthetic induction until the patient is fully awake)
  • Presence of bradycardia in the cardioscope as reported for the age.(from anesthetic induction until the patient is fully awake)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Luci-a Giraldo Salazar

MD, Anestesiologist

Universidad de Antioquia

研究点 (2)

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