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临床试验/NCT00570414
NCT00570414已完成不适用

Airway Management in Children Undergoing Adenotonsillectomies Under General Anesthesia; a Comparison of the Endotracheal Tube and the Laryngeal Mask Airway

Sykehuset Telemark2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2007年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
2
主要终点
Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score)

研究概览

简要总结

Secure airway management is the basis of all anesthesiological practice. Of particular importance is the securing of patients' airway passages when the surgical procedure itself poses a threat to a patient's airway, as is the case in all procedures involving the upper respiratory pathways. When adenoidectomies, tonsillectomies and combined adenotonsillectomies are performed, blood from the surgical area will present a respiratory threat to unsecured airways. The traditional opinion has been that endotracheal intubation is the safest method of preventing aspiration.

The laryngeal mask was introduced in 1983 as an alternative to the endotracheal tube. In 1990, the flexible, reinforced laryngeal mask airway was introduced, intended for use during surgical procedures involving the mouth and throat. The laryngeal mask airway has several potential advantages over the endotracheal tube. It is inserted blindly, without laryngoscopy. This leads to reduced oropharyngeal or laryngeal stimulation and injury, and therefore minimal activation of respiratory and circulatory reflexes. The laryngeal mask airway can be placed without the use of muscle relaxants, avoiding potential side effects such as apnea, hyperkalemia and anaphylaxis. In addition the laryngeal mask airway can remain in the throat until the patient awakes, virtually eliminating the danger of postoperative aspiration.

Several international studies have described the advantages of the laryngeal mask airway over endotracheal intubation during ear, nose and throat surgery in children. The general impression is that there is a widespread routine implementation of the laryngeal mask airway. In Norway, however, this practice has been limited. As far as we know, only Namsos Hospital uses this procedure as its first choice. At Telemark Hospital we tested the use of laryngeal mask airway on 150 patients between May and December 2006. The results so far have been promising, and we have had no serious complications.

Hypothesis:

In children undergoing adenotonsillectomies, a laryngeal mask airway provides greater patient satisfaction (judged by reduced pain, nausea and vomiting) and greater effectivity (judged by reduced time in surgery), compared with the endotracheal tube. The laryngeal mask provides as much as or greater secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.

详细描述

Registration:

Preoperative: Age, height, weight, medication, asthma/allergy, possible current respiratory infection

Peroperative: Type of procedure, tube size/laryngeal mask, type of tongue blade, highest/lowest SpO2, highest/lowest ET CO2, highest/lowest pulse, length of surgery, total operating room time, operator, medication. Reason must be given if converting from laryngeal mask to tube; lack of visibility for operator, laryngeal mask not possible to place, unacceptable leakage before placing tongue blade, occlusion after placement of tongue blade.

Postoperative: Pain judged by need for opiates (VAS, crying, agitation, tachycardia), nausea judged by gagging/vomiting, total time in recovery, rebleeding judged by reoperation.

Anesthesia:

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
None

入排标准

年龄范围
3 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 10-60 kg
  • Elective adenotomy, tonsillectomy or combined adenotonsillectomy under general anesthesia.
  • Written and oral informed parental consent.

排除标准

  • ASA III or higher.
  • Weight < 10 kg or weight > 60 kg.
  • Congenital malformations of the mouth or throat.

结局指标

主要结局

Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score)

时间窗: 24 hrs

次要结局

  • Secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.(24 hrs)
  • Effectivity (judged by reduced time in surgery)(1 hrs)

研究者

发起方
Sykehuset Telemark
申办方类型
Other Gov

研究点 (2)

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