跳至主要内容
临床试验/NCT02325076
NCT02325076已完成不适用

The Association Between Pulmonary Function Tests and Difficult Airway

Tokat Gaziosmanpasa University2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2013年12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
202
试验地点
2
主要终点
Pulmonary function test differences between Mallampati 3 and 4 patients

研究概览

简要总结

The airflow moving from mouth to the lungs, which can be measured by pulmonary function tests, may be affected by the anatomic disorders of the upper airway. Difficult airway can be considered as the anatomic disorder of the upper airway as well. Therefore, there can be a relationship between difficult airway and pulmonary function tests. The purpose of this study is to elucidate the association between the pulmonary function tests and difficult airway.

详细描述

After approval of the Gaziosmanpasa University Clinical Trials Ethics Committee, patients those admitted to the anesthesiology outpatient unit will informed about the study. And pulmonary function tests by using Spirodoc® will be performed to those willing to participate in the study. Measurements of the pulmonary function tests, and measurements belong to difficult airway will be recorded.

In the operating theatre, after induction of anesthesia, the difficult intubation measurements will be recorded.

Normality and variance will be tested using One Sample Kolmogorov-Smirnov test, skewness, kurtosis and histograms for each variable. Quantitative data will present as means and standard deviation, and qualitative data as frequency and percentage. Depending on these results, Spearman's correlation analysis will perform to show the association between pulmonary function tests and difficult airway measurements. Analyses were conducted using the Statistical Package for Social Sciences program (SPSS Inc., Chicago, IL), version 20.0. Statistical significance for all analyses was set at p < 0.05.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients whose admitted to the Gaziosmanpasa University, Medical Faculty, Anesthesiology and Reanimation outpatient unit
  • Patients whose will be planned to undertake a surgical operation under general anesthesia and those performed tracheal intubation to secure the airway.
  • An American Society of Anesthesiologists score of 1 or 2

排除标准

  • Patient whose planned to undertake a surgical operation in the departments of ear-nose-throat, cardiac and vascular surgery, plastic and reconstructive surgery
  • Patients with a history of chronic obstructive lung diseases
  • Patients with a history of surgery on the neck
  • Patients with a history of mandibular surgery

结局指标

主要结局

Pulmonary function test differences between Mallampati 3 and 4 patients

时间窗: eighteen months

次要结局

  • Maximum mouth opening(eighteen months)
  • Mean inspiratory flow(eighteen months)
  • Measurement of neck circumference(eighteen months)
  • Cormack-Lehane grade(eighteen months)
  • Percentage of glottic opening(eighteen months)
  • Upper lip bite test score(eighteen months)
  • Sterno-mental distance(eighteen months)
  • Thyromental distance(eighteen months)
  • The ratio of forced expiratory flow 25% to forced expiratory flow 75%(eighteen months)

研究者

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serkan Dogru

Assistant Professor, MD

Tokat Gaziosmanpasa University

研究点 (2)

Loading locations...

相似试验