Difficult IntubationNCT02814266
Difficult Intubation and Anthropometric Measurement
A study testing difficult intubation and easy intubation in people with Difficult Intubation, run by Trakya University.
Trial summary
OBJECTIVE: This study aimed to determine the sensitivity and specificity of various anatomic measurements alone or in combination in predicting difficult intubation. The investigators hypothesized that goniomastoid distance, thyrogonial distance and tongue movements are sensitive and specific tests for predicting… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- difficult intubation and easy intubation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jun 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing abdominal surgery with general anesthesia
- Able to sit
Who cannot join
- Enable to sit,
- Patients had head or neck surgery,
- Patients with unstable cardiological and respiratory hemodynamic symptoms,
- Dental prosthesis
About this study
Official title: Trakya University, Faculty of Medicine, Department of Anatomy, Edirne, Turkey
OBJECTIVE: This study aimed to determine the sensitivity and specificity of various anatomic measurements alone or in combination in predicting difficult intubation. The investigators hypothesized that goniomastoid distance, thyrogonial distance and tongue movements are sensitive and specific tests for predicting difficult intubation MATERIALS AND METHODS: The investigators included the data of 170 patients (85 difficult intubation and 85 easy intubation) who underwent an abdominal surgery under general anesthesia. Patients in difficult intubation (n=85) and easy intubation (n=85) groups were matched by age, BMI, and gender. Intubation difficulty scale (IDS) scores were recorded. Upward and downward maximal protrusions of tongue (UMPT and DMPT, respectively) were evaluated in all patients. Anthropometric measurements were measured.
Read the detailed description
To define the tongue protrusion tests, anatomic landmarks and horizontal lines were used. The first horizontal line (lower target line) was passing through the midpoint of the distance between stomion to mentum (mandible height) and the second horizontal line (upper target line) was passing through the midpoint of the distance from subnasal to stomion (upper lip height). The horizontal lines were drawn with an erasable marker pen on the each patient's face. In the sitting position, patients were asked to make maximal tongue protrusion upward (UMPT) and downward (DMPT) in anatomical neutral position. The inability of the tip of the tongue to reach to the target line was scored "1" and ability of the tongue tip to reach or pass the target line was scored "2
- Conditions
- Difficult Intubation
- Being tested
- difficult intubation, easy intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difficult intubationOther
Goniomastoid Distance: The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. Thyrogonial Distance: The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open.
easy intubationOther
Goniomastoid Distance: The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. Thyrogonial Distance: The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open.
| Study group | Role | What they receive |
|---|---|---|
| difficult intubation | Other | Intubation difficulty score >5 Receives: Other: difficult intubation; Other: easy intubation |
| Easy intubation | Other | Intubation difficulty score >5 Receives: Other: difficult intubation; Other: easy intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
thyrogonial distance
thyrogonial distance in centimeter (cm)The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open.
Measured: 5 months
Secondary outcomes (1)
Goniomastoid distance
goniomastoid distance in centimeter(cm) The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aliyilmaz, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814266
- Sponsor's protocol ID
- TrakyaUniver
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trakya University, Faculty of Medicine, Department of Anatomy, Edirne, Turkey
- ClinicalTrials.gov ID
- NCT02814266
- Acronym / sponsor ID
- TrakyaUniver
- Conditions
- Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jun 2016 (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.
OBJECTIVE: This study aimed to determine the sensitivity and specificity of various anatomic measurements alone or in combination in predicting difficult intubation. The investigators hypothesized that goniomastoid distance, thyrogonial distance and tongue movements are sensitive and specific tests for predicting difficult intubation MATERIALS AND METHODS: The investigators included the data of 170 patients (85 difficult intubation and 85 easy intubation) who underwent an abdominal surgery under general anesthesia. Patients in difficult intubation (n=85) and easy intubation (n=85) groups were matched by age, BMI, and gender. Intubation difficulty scale (IDS) scores were recorded. Upward and downward maximal protrusions of tongue (UMPT and DMPT, respectively) were evaluated in all patients. Anthropometric measurements were measured.
Detailed description
To define the tongue protrusion tests, anatomic landmarks and horizontal lines were used. The first horizontal line (lower target line) was passing through the midpoint of the distance between stomion to mentum (mandible height) and the second horizontal line (upper target line) was passing through the midpoint of the distance from subnasal to stomion (upper lip height). The horizontal lines were drawn with an erasable marker pen on the each patient's face. In the sitting position, patients were asked to make maximal tongue protrusion upward (UMPT) and downward (DMPT) in anatomical neutral position. The inability of the tip of the tongue to reach to the target line was scored "1" and ability of the tongue tip to reach or pass the target line was scored "2
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| difficult intubation | Other | Other: difficult intubation, Other: easy intubationIntubation difficulty score >5 |
| Easy intubation | Other | Other: difficult intubation, Other: easy intubationIntubation difficulty score >5 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing abdominal surgery with general anesthesia
- Able to sit
Key exclusion criteria (4 listed)
- Enable to sit,
- Patients had head or neck surgery,
- Patients with unstable cardiological and respiratory hemodynamic symptoms,
- Dental prosthesis
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 |
|---|---|---|
| difficult intubationGoniomastoid Distance: The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. Thyrogonial Distance: The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open. | Other | Easy intubation, difficult intubation |
| easy intubationGoniomastoid Distance: The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. Thyrogonial Distance: The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open. | Other | Easy intubation, difficult intubation |
Primary outcome
thyrogonial distance
Time frame: 5 months
thyrogonial distance in centimeter (cm)The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open.
1 secondary outcome
Goniomastoid distance
Time frame: 5 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 27 Jun 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing difficult intubation and easy intubation in people with Difficult Intubation, run by Trakya University.
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 2 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
thyrogonial distance (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2016; AzTrials last refreshed its copy on 30 Oct 2026.