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临床试验/NCT05218707
NCT05218707招募中不适用

Influence of Oropharyngeal Airway on the Incidence of Airway Complications Following LMA Removal Under Deep Anaesthesia in Children

Aga Khan University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
230
试验地点
1
主要终点
Oxygen saturation

研究概览

简要总结

Laryngeal Mask Airway has been used in paediatric anaesthesia since the 1990's. Clinical practice in paedeatric anaesthesia for Laryngeal Mask Airway removal varies and there is no standard of care.

In children removing the Laryngeal Mask Airway under deep inhalational anaesthesia has some advantages compared to awake, but may be associated with higher rate of complications when Laryngeal Mask Airway is removed in supine compared to lateral position. On the other hand deep anaesthesia may cause airway obstruction due to reduction in tone of upper airway muscles in some patients. An oropharangeal airway may prevent this. This aspect had not been studied before and represent a gap in literature.

Study Hypothesis:

Airway complications associated with Laryngeal Mask Airway removal under deep anaesthesia are same with or without insertion of an oral airway. Alternate hypothesis is that airway complications be less if an air way is inserted at the end of anaesthesia.

Objective:

The present study was designed to observe any difference in immediate complication after removal of LMA in supine head down position under deep anaesthesia with or without insertion of an oro-pharyngeal airway. Airway complications that we will observe are desaturation <92%, stridor, excessive secretions, laryngospasm, retching, vomiting, coughing, trauma to the soft tissues and damage to the teeth.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I and II patients aged 2-10 years undergoing surgery where anaesthesia with LMA is considered appropriate.

排除标准

  • Patients undergoing surgery involving soiling of the airway
  • Patients with conditions associated with higher incidence of gastrooseophageal reflux
  • Presence of active upper respiratory tract infection (URI)
  • Emergency Surgery

结局指标

主要结局

Oxygen saturation

时间窗: Day 1

Oxygen saturation \<92% will be considered as complication

Stridor

时间窗: Day 1

The presence of noisy breathing occurring through obstructed airflow. We clinically measure it by auscultation of the nose, oropharynx, neck and chest.

次要结局

  • laryngospasm(Day 1)

研究者

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

Khalid Siddiqui

Assistant Professor

Aga Khan University

研究点 (1)

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