The Association Between Pulmonary Function Tests and Difficult Airway

NCT ID: NCT02325076

Last Updated: 2016-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-02-28

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.

Conditions

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Airway Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Spirodoc

One time during examination at the outpatient unit

Group Type EXPERIMENTAL

Spirodoc

Intervention Type DEVICE

A device to detect the physical condition of the lungs

Interventions

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Spirodoc

A device to detect the physical condition of the lungs

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Serkan Dogru

Assistant Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serkan Dogru, Assist.Prof.

Role: PRINCIPAL_INVESTIGATOR

Tokat Gaziosmanpasa University

Locations

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Gaziosmanpasa University

Tokat Province, Tokat Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 8630569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19010290 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27866310 (View on PubMed)

Other Identifiers

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13-KAEK-215

Identifier Type: -

Identifier Source: org_study_id

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