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Clinical Trials/NCT02325076
NCT02325076
Completed
Not Applicable

The Association Between Pulmonary Function Tests and Difficult Airway

Tokat Gaziosmanpasa University1 site in 1 country202 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Obstruction
Sponsor
Tokat Gaziosmanpasa University
Enrollment
202
Locations
1
Primary Endpoint
Pulmonary function test differences between Mallampati 3 and 4 patients
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Tokat Gaziosmanpasa University
Responsible Party
Principal Investigator
Principal Investigator

Serkan Dogru

Assistant Professor, MD

Tokat Gaziosmanpasa University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pulmonary function test differences between Mallampati 3 and 4 patients

Time Frame: eighteen months

Secondary Outcomes

  • 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)

Study Sites (1)

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