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临床试验/NCT03931122
NCT03931122已完成不适用

Comparison of Weight-based Versus External Ear-size Based Technique for Selection of Laryngeal Mask Airway in Pediatric Surgical Patients.

Aga Khan University2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2019年12月11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
136
试验地点
2
主要终点
Adequacy of Ventilation

研究概览

简要总结

Laryngeal Mask Airway (LMA) is widely used in pediatric surgical patients. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight but this method has several limitations. To overcome these concerns, various alternatives have been tried by different researchers, one of them is external ear size for LMA size selection. Investigators therefore would like to know whether the external ear size based method can be used for LMA size selection in pediatric surgical patients in Pakistan.

详细描述

OBJECTIVE:

to determine whether external ear-size is non-inferior to weight for LMA size selection in pediatric surgical patients.

INTRODUCTION:

The Laryngeal Mask Airway (LMA) is widely used in pediatric population. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight. However, this method has several limitations, the range of weight for a particular size is very wide, it may not be appropriate for overweight or underweight children as it is based on actual body weight rather than ideal body weight, in emergency situations where weight of the patient is unknown the correlation between weight and size of LMA is impossible, and finally weight based recommendation may not be suitable as development of the child's oropharyngeal cavity is related to height and age rather than weight. All these factors may lead to inappropriate size selection, which may result in larger sized LMA causing trauma/injury to the airway and smaller ones causing obstruction or insufficient ventilation. To overcome these concerns various alternatives to weight based technique have been tried by different researchers in both adult and pediatric patients, one of them is external ear size. Literature revealed differences in external ear size dimensions in different ethnic population and the investigator's literature search failed to reveal any local data/study in Pakistani pediatric patients where external ear size was compared or used for size selection of the LMA. The investigators therefore would like to know whether the external ear size based method can be used for LMA size selection in pediatric surgical patients in Pakistan.

HYPOTHESIS:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

One of the investigators will record patients' weight and external ear measurements in the study proforma. Patient's medical record (MR) number will then be send to the Research assistant/ Statistician for randomization into one of the groups (Group A or Group B). On the day of surgery, research assistant will hand over patient's group allocation in a sealed opaque envelop to one of the investigators who will not be the primary anesthetist. This investigator will determine the LMA size according to the group allocation. In case the dimensions fall between the two sizes of LMA in the ear size group, the closest one will be selected. After writing LMA size in the proforma it will be handed over to the primary anesthetist who will be blinded to patient's group allocation. Primary anesthetist (who has an experience of minimum 50 LMA insertions) will use the LMA.

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All children aged between 6 months to 18 years of age of either sex
  • American Society of Anesthesiologist (ASA) Classification I-II
  • Elective surgical procedures in whom an LMA will be indicated
  • Procedure lasting up to 2hrs

排除标准

  • Any external ear morphological abnormality
  • Previous external ear surgeries
  • Patient/Parent refusal
  • Children with oropharyngeal lesion
  • Any patient conditions (Gastroesophageal Re-flux Disease [GERD], hiatal hernia, incomplete NPO, bowel obstruction etc.) or procedures requiring rapid sequence induction and intubation
  • History of Upper respiratory tract infection (URTI) within the last 2 weeks

结局指标

主要结局

Adequacy of Ventilation

时间窗: 1 minute

Adequacy of ventilation: will be judged by an oxygen saturation of greater than or equal to 95% at a Fractional Inspired Oxygen concentration (FiO2) less than 0.5 and an end-tidal carbon dioxide (ETCO2) of 35-45 mmHg at a tidal volume of 6- 8 ml/kg Actual Body Weight (ABW) at peak airway pressure less than the oropharyngeal leak pressure (OLP), and by adjusting the respiratory rate (RR).

Proper Placement

时间窗: 1 minute

Proper LMA placement will be assessed by chest expansion on positive pressure ventilation, absence of audible leak and a square wave capnograph waveform.

次要结局

  • Oropharyngeal Leak Pressure (OLP)(30 seconds)
  • Leak fraction (LF)(1 minute)
  • Incidence of mucosal injury and laryngospasm(1 minute)

研究者

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

Muhammad Qamarul Hoda

Professor, Department of Anesthesiology

Aga Khan University

研究点 (2)

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