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The Association Between Pulmonary Function Tests and Difficult Airway

Primary Purpose

Airway Obstruction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spirodoc
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Airway Obstruction focused on measuring Airway Management, intubation, pulmonary function test

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gaziosmanpasa University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spirodoc

Arm Description

One time during examination at the outpatient unit

Outcomes

Primary Outcome Measures

Pulmonary function test differences between Mallampati 3 and 4 patients

Secondary Outcome Measures

Cormack-Lehane grade
Cormack-Lehane grade
Maximum mouth opening
Maximum mouth opening
Percentage of glottic opening
Percentage of glottic opening
Upper lip bite test score
Upper lip bite test score
Measurement of neck circumference
Measurement of neck circumference
Sterno-mental distance
Sterno-mental distance
Thyromental distance
Thyromental distance
Mean inspiratory flow
The ratio of forced expiratory flow 25% to forced expiratory flow 75%

Full Information

First Posted
December 11, 2014
Last Updated
February 10, 2016
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT02325076
Brief Title
The Association Between Pulmonary Function Tests and Difficult Airway
Official Title
The Association Between Pulmonary Function Tests and Difficult Airway
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction
Keywords
Airway Management, intubation, pulmonary function test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spirodoc
Arm Type
Experimental
Arm Description
One time during examination at the outpatient unit
Intervention Type
Device
Intervention Name(s)
Spirodoc
Intervention Description
A device to detect the physical condition of the lungs
Primary Outcome Measure Information:
Title
Pulmonary function test differences between Mallampati 3 and 4 patients
Time Frame
eighteen months
Secondary Outcome Measure Information:
Title
Cormack-Lehane grade
Description
Cormack-Lehane grade
Time Frame
eighteen months
Title
Maximum mouth opening
Description
Maximum mouth opening
Time Frame
eighteen months
Title
Percentage of glottic opening
Description
Percentage of glottic opening
Time Frame
eighteen months
Title
Upper lip bite test score
Description
Upper lip bite test score
Time Frame
eighteen months
Title
Measurement of neck circumference
Description
Measurement of neck circumference
Time Frame
eighteen months
Title
Sterno-mental distance
Description
Sterno-mental distance
Time Frame
eighteen months
Title
Thyromental distance
Description
Thyromental distance
Time Frame
eighteen months
Title
Mean inspiratory flow
Time Frame
eighteen months
Title
The ratio of forced expiratory flow 25% to forced expiratory flow 75%
Time Frame
eighteen months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serkan Dogru, Assist.Prof.
Organizational Affiliation
Tokat Gaziosmanpasa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60200
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
8630569
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.
Results Reference
background
PubMed Identifier
19010290
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.
Results Reference
background
PubMed Identifier
27866310
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.
Results Reference
derived

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The Association Between Pulmonary Function Tests and Difficult Airway

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