NCT02325076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

December 11, 2014

Last Update Submit

February 10, 2016

Conditions

Keywords

Airway Managementintubationpulmonary function test

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function test differences between Mallampati 3 and 4 patients

    eighteen months

Secondary Outcomes (9)

  • Cormack-Lehane grade

    eighteen months

  • Maximum mouth opening

    eighteen months

  • Percentage of glottic opening

    eighteen months

  • Upper lip bite test score

    eighteen months

  • Measurement of neck circumference

    eighteen months

  • +4 more secondary outcomes

Study Arms (1)

Spirodoc

EXPERIMENTAL

One time during examination at the outpatient unit

Device: Spirodoc

Interventions

SpirodocDEVICE

A device to detect the physical condition of the lungs

Spirodoc

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, Tokat Province, 60200, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 8630569BACKGROUND
  • 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.

    PMID: 19010290BACKGROUND
  • 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.

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Serkan Dogru, Assist.Prof.

    Tokat Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 24, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations