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Completed

NCT Number: NCT02325076

The Association Between Pulmonary Function Tests and Difficult Airway

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirodoc

Device

A device to detect the physical condition of the lungs

Primary outcomes

  1. Pulmonary function test differences between Mallampati 3 and 4 patients

    Time frame: eighteen months

Secondary outcomes

  1. Cormack-Lehane grade

    Time frame: eighteen months

    Cormack-Lehane grade

  2. Maximum mouth opening

    Time frame: eighteen months

    Maximum mouth opening

  3. Percentage of glottic opening

    Time frame: eighteen months

    Percentage of glottic opening

  4. Upper lip bite test score

    Time frame: eighteen months

    Upper lip bite test score

  5. Measurement of neck circumference

    Time frame: eighteen months

    Measurement of neck circumference

  6. Sterno-mental distance

    Time frame: eighteen months

    Sterno-mental distance

  7. Thyromental distance

    Time frame: eighteen months

    Thyromental distance

  8. Mean inspiratory flow

    Time frame: eighteen months

  9. The ratio of forced expiratory flow 25% to forced expiratory flow 75%

    Time frame: eighteen months

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2014
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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