Airway ObstructionNCT02325076
The Association Between Pulmonary Function Tests and Difficult Airway
A study testing Spirodoc in people with Airway Obstruction, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Spirodoc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, Tokat Province, 60200
About this study
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.
Read the 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.
- Conditions
- Airway Obstruction
- Being tested
- Spirodoc
- Keywords
- Airway Management, intubation, pulmonary function test
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirodocDevice
A device to detect the physical condition of the lungs
| Study group | Role | What they receive |
|---|---|---|
| Spirodoc | Experimental | One time during examination at the outpatient unit Receives: Device: Spirodoc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test differences between Mallampati 3 and 4 patients
Measured: eighteen months
Secondary outcomes (9)
Cormack-Lehane grade
Cormack-Lehane grade
Measured: eighteen months
Maximum mouth opening
Maximum mouth opening
Measured: eighteen months
Percentage of glottic opening
Percentage of glottic opening
Measured: eighteen months
Upper lip bite test score
Upper lip bite test score
Measured: eighteen months
Measurement of neck circumference
Measurement of neck circumference
Measured: eighteen months
Sterno-mental distance
Sterno-mental distance
Measured: eighteen months
Thyromental distance
Thyromental distance
Measured: eighteen months
Mean inspiratory flow
Measured: eighteen months
The ratio of forced expiratory flow 25% to forced expiratory flow 75%
Measured: eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Dogru, Tokat Gaziosmanpasa University
- Investigators
- Serkan Dogru, Assist.Prof., Principal investigator, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325076
- Sponsor's protocol ID
- 13-KAEK-215
- Status last verified
- Feb 2016
- First submitted
- 11 Dec 2014
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1164/ajrccm.153.3.8630569.
PubMed 8630569Tucker 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.
PubMed 19010290Dogru 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.
PubMed 27866310
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Pulmonary Function Tests and Difficult Airway
- ClinicalTrials.gov ID
- NCT02325076
- Acronym / sponsor ID
- 13-KAEK-215
- Conditions
- Airway Obstruction
- Keywords
- Airway Management, intubation, pulmonary function test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spirodoc | Experimental | Device: SpirodocOne time during examination at the outpatient unit |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirodocA device to detect the physical condition of the lungs | Device | Spirodoc |
Primary outcome
Pulmonary function test differences between Mallampati 3 and 4 patients
Time frame: eighteen months
9 secondary outcomes
Cormack-Lehane grade
Time frame: eighteen months
Maximum mouth opening
Time frame: eighteen months
Percentage of glottic opening
Time frame: eighteen months
Upper lip bite test score
Time frame: eighteen months
Measurement of neck circumference
Time frame: eighteen months
Sterno-mental distance
Time frame: eighteen months
Thyromental distance
Time frame: eighteen months
Mean inspiratory flow
Time frame: eighteen months
The ratio of forced expiratory flow 25% to forced expiratory flow 75%
Time frame: eighteen months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Background: PubMed 8630569Leiter 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.
- Background: PubMed 19010290Tucker 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.
- Derived from this study: PubMed 27866310Dogru 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Dogru, Assist.Prof. principal investigator
Tokat Gaziosmanpasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirodoc in people with Airway Obstruction, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test differences between Mallampati 3 and 4 patients (time frame: eighteen months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325076, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.