The Association Between Pulmonary Function Tests and Difficult Airway

• Sponsor: Tokat Gaziosmanpasa University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02325076
• Collaborator: (none)
• Enrollment: 202
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 14.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Obstruction	Device: Spirodoc	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 202 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Association Between Pulmonary Function Tests and Difficult Airway
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spirodoc One time during examination at the outpatient unit	Device: Spirodoc; A device to detect the physical condition of the lungs

Outcome Measures

Primary Outcome Measures

1. Pulmonary function test differences between Mallampati 3 and 4 patients [eighteen months]

Secondary Outcome Measures

1. Cormack-Lehane grade [eighteen months]

   Cormack-Lehane grade

2. Maximum mouth opening [eighteen months]

   Maximum mouth opening

3. Percentage of glottic opening [eighteen months]

   Percentage of glottic opening

4. Upper lip bite test score [eighteen months]

   Upper lip bite test score

5. Measurement of neck circumference [eighteen months]

   Measurement of neck circumference

6. Sterno-mental distance [eighteen months]

   Sterno-mental distance

7. Thyromental distance [eighteen months]

   Thyromental distance

8. Mean inspiratory flow [eighteen months]

9. The ratio of forced expiratory flow 25% to forced expiratory flow 75% [eighteen months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaziosmanpasa University	Tokat		Turkey	60200

Sponsors and Collaborators

• Tokat Gaziosmanpasa University

Investigators

• Principal Investigator: Serkan Dogru, Assist.Prof., Tokat Gaziosmanpasa University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Serkan Dogru, Assistant Professor, MD, Tokat Gaziosmanpasa University
• ClinicalTrials.gov Identifier: NCT02325076
• Other Study ID Numbers: 13-KAEK-215
• First Posted: Dec 24, 2014
• Last Update Posted: Feb 11, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by Serkan Dogru, Assistant Professor, MD, Tokat Gaziosmanpasa University: Airway Management; intubation; pulmonary function test
• Additional relevant MeSH terms: Airway Obstruction

Study Results

No Results Posted as of Feb 11, 2016