The Association Between Pulmonary Function Tests and Difficult Airway

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Association Between Pulmonary Function Tests and Difficult Airway

Conditions
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Airway Obstruction

Intervention / Treatment
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* Device: Spirodoc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirodoc<br>One time during examination at the outpatient unit | Device: Spirodoc<br>* A device to detect the physical condition of the lungs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test differences between Mallampati 3 and 4 patients |  | eighteen months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cormack-Lehane grade | Cormack-Lehane grade | eighteen months | 
| Maximum mouth opening | Maximum mouth opening | eighteen months | 
| Percentage of glottic opening | Percentage of glottic opening | eighteen months | 
| Upper lip bite test score | Upper lip bite test score | eighteen months | 
| Measurement of neck circumference | Measurement of neck circumference | eighteen months | 
| Sterno-mental distance | Sterno-mental distance | eighteen months | 
| Thyromental distance | Thyromental distance | eighteen months | 
| Mean inspiratory flow |  | eighteen months | 
| The ratio of forced expiratory flow 25% to forced expiratory flow 75% |  | eighteen months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway Management, intubation, pulmonary function test