- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02814266
Difficult Intubation and Anthropometric Measurement
June 22, 2016 updated by: aliyilmaz, Trakya University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Undergoing abdominal surgery with general anesthesia
- Able to sit
Exclusion Criteria:
- Enable to sit,
- Patients had head or neck surgery,
- Patients with unstable cardiological and respiratory hemodynamic symptoms,
- Dental prosthesis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: difficult intubation
Intubation difficulty score >5
|
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.
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.
|
|
Other: Easy intubation
Intubation difficulty score >5
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goniomastoid distance
Time Frame: 5 months
|
goniomastoid distance in centimeter(cm) The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open.
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
June 14, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (Estimate)
June 27, 2016
Study Record Updates
Last Update Posted (Estimate)
June 27, 2016
Last Update Submitted That Met QC Criteria
June 22, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- TrakyaUniver
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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