Clinical trial NCT02325076: The Association Between Pulmonary Function Tests and Difficult Airway
Official title: The Association Between Pulmonary Function Tests and Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Obstruction
Keywords: Airway Management
intubation
pulmonary function test
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Pulmonary function test differences between Mallampati 3 and 4 patients
timeFrame: eighteen months
Secondary outcomes:
measure: Cormack-Lehane grade
timeFrame: eighteen months
measure: Maximum mouth opening
timeFrame: eighteen months
measure: Percentage of glottic opening
timeFrame: eighteen months
measure: Upper lip bite test score
timeFrame: eighteen months
measure: Measurement of neck circumference
timeFrame: eighteen months
measure: Sterno-mental distance
timeFrame: eighteen months
measure: Thyromental distance
timeFrame: eighteen months
measure: Mean inspiratory flow
timeFrame: eighteen months
measure: The ratio of forced expiratory flow 25% to forced expiratory flow 75%
timeFrame: eighteen months
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Tokat Gaziosmanpasa University
name: Serkan Dogru, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1164/ajrccm.153.3.8630569.
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.
citation: Dogru S, Karaman T, Sahin A, Tapar H, Karaman S, Arici S, Suren M, Kaya Z, Somuk BT. Prediction of difficult laryngoscopy using spirometry: a pilot study. J Clin Monit Comput. 2017 Dec;31(6):1115-1121. doi: 10.1007/s10877-016-9961-2. Epub 2016 Nov 19.