The Association Between Pulmonary Function Tests and Difficult Airway

Airway Obstruction Clinical Trial

Official title:

The Association Between Pulmonary Function Tests and Difficult Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325076
• Other study ID #: 13-KAEK-215
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: February 10, 2016
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

Device:
• Spirodoc
A device to detect the physical condition of the lungs

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Leiter JC. Upper airway shape: Is it important in the pathogenesis of obstructive sleep apnea? Am J Respir Crit Care Med. 1996 Mar;153(3):894-8. Review. — View Citation

Tucker Woodson B. Structural effectiveness of pharyngeal sleep apnea surgery. Sleep Med Rev. 2008 Dec;12(6):463-79. doi: 10.1016/j.smrv.2008.07.010. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function test differences between Mallampati 3 and 4 patients		eighteen months	No
Secondary	Cormack-Lehane grade	Cormack-Lehane grade	eighteen months	No
Secondary	Maximum mouth opening	Maximum mouth opening	eighteen months	No
Secondary	Percentage of glottic opening	Percentage of glottic opening	eighteen months	No
Secondary	Upper lip bite test score	Upper lip bite test score	eighteen months	No
Secondary	Measurement of neck circumference	Measurement of neck circumference	eighteen months	No
Secondary	Sterno-mental distance	Sterno-mental distance	eighteen months	No
Secondary	Thyromental distance	Thyromental distance	eighteen months	No
Secondary	Mean inspiratory flow		eighteen months	No
Secondary	The ratio of forced expiratory flow 25% to forced expiratory flow 75%		eighteen months	No