跳至主要内容
临床试验/NCT03105388
NCT03105388已完成不适用

STOP-BANG Score and Cephalometry in Prediction of Difficult Airway in Patients at Risk of Obstructive Sleep Apnoea

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015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
入组人数
41
试验地点
1
主要终点
Correlation between STOP-BANG score and Cormack Lehance view.

研究概览

简要总结

Incidence of difficult laryngoscopy and difficult intubation are higher among patients with obstructive sleep apnoea (OSA). Precision in making the diagnosis and predicting difficult laryngoscopy preoperatively may help to reduce anesthetic complications. This study was designed to evaluate the diagnostic performance of combined and non-combined radiological parameter (mandibulohyoid distance) and STOP-BANG questionnaire as screening tool.

.

Methodology:

Forty-one subjects who were at risk of OSA, undergoing general anaesthesia will be included using STOP-BANG questionnaire. Mandibulohyoid distance and other radiological parameters will be measured from lateral cephalometry. Evaluation for difficult laryngoscopy will be carried out during anaesthesia.

详细描述

RESEARCH DESIGN:Cross sectional study

STUDY HYPOTHESES: There is a significant correlation between STOP-BANG score and cephalometric measurement with difficult intubation in patients at risk of Obstructive Sleep Apnoea.

Null hypothesis:

There is no significant correlation between STOP-BANG score and cephalometric measurement with difficult intubation in patients at risk of Obstructive Sleep Apnoea.

SAMPLE SIZE ESTIMATION This is a cross sectional study with 2 means. For objective 1, sample size calculation is done using power and sample size program version 3.1.2

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consenting patient of age 18 years old and above.
  • American Society of Anesthesiologist (ASA) physical status I and II.
  • Age range (18- 75yo).
  • Operation requiring general anesthesia
  • All patient at risk of Obstructive Sleep Apnea with STOP-BANG questionnaire scoring ≥ 3 positive response are selected on the day of admission.

排除标准

  • Pregnant patient.
  • Not fasted as least for 6 hours
  • Has gastroesophageal reflux.

结局指标

主要结局

Correlation between STOP-BANG score and Cormack Lehance view.

时间窗: May 2015 - February 2016

STOP-BANG score (Snoring, Tired during daytime, Observed apnoea, High blood pressure, BMI, Age, Neck circumference: Neck circumference, Gender)

次要结局

  • Correlation between Mandibular-hyoid distance and Cormack Lehance view.(May 2015 - February 2016)

研究者

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

Rhendra Hardy Mohamad Zaini

Senior consultant anesthetist and lecturer

Universiti Sains Malaysia

研究点 (1)

Loading locations...

相似试验