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临床试验/NCT03215121
NCT03215121已完成不适用

Comparative Evaluation of One Handed Versus Two Handed Mask Holding Techniques in Children During Induction of Anesthesia

Nemours Children's Clinic2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Work of breathing

研究概览

简要总结

During induction of anesthesia in children, the investigators have observed significant variability in mask holding technique at our institution among different anesthesia practitioners. Some hold the face mask using one hand and others use two hands. The aim of our study is to comparatively evaluate the extent of airway obstruction in children whilst anesthetic mask is held with one hand with jaw thrust versus mask held using two hands with chin lift by anesthesia provider during induction of anesthesia in children.

详细描述

In a prospective, randomized and controlled study, 60 children with documented obstructive sleep apnea (from sleep study or history obtained from the parent of bothersome snoring, witnessed apnea which interrupts the snoring and/or gasping and choking sensations that arouse the patient from sleep) due to enlarged tonsils and adenoid scheduled for tonsillectomy and adenoidectomy surgery will be enrolled in the study. Children will be randomly divided in three groups of 20 each based on the induction technique used:

Group --1: Induction of anesthesia started as follows while children are breathing spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw thrust - 20 sec

Group 2 - Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec

Group 3 - Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 20 sec and then switch to one hand + chin lift- 20 sec

Premedication with midazolam as per standard protocol, will be administered prior to taking the patients to the operating room. Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between 1 to 8 years of age Scheduled for Tonsillectomy & adenoidectomy Documented evidence of obstructive sleep apnea ASA I and II

排除标准

  • Children with abnormal airway anatomy ASA III and over

结局指标

主要结局

Work of breathing

时间窗: 20 - 40 seconds

Phase angle

次要结局

  • Airway Obstruction Rating Scale 0 - 3(20-40 seconds)
  • Laryngospasm(20-40 seconds)
  • Breath holding(20-40 seconds)
  • Labored breathing(20-40 seconds)
  • Rib cage movement(20-40 seconds)

研究者

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

Dinesh Choudhry

Pediatric Anesthesiologist and Director of Pain Service, Principal Investigator, Associate Professor of Anesthesiology

Nemours Children's Clinic

研究点 (2)

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