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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02814266
Other study ID # TrakyaUniver
Secondary ID
Status Completed
Phase N/A
First received June 14, 2016
Last updated June 22, 2016
Start date November 2015
Est. completion date June 2016

Study information

Verified date June 2016
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics CommitteeTurkey: Ministry of Health
Study type Interventional

Clinical 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 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date June 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
difficult intubation
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 intubation
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Outcome

Type Measure Description Time frame Safety issue
Primary thyrogonial distance thyrogonial distance in centimeter (cm)The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open. 5 months No
Secondary Goniomastoid distance goniomastoid distance in centimeter(cm) The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. 5 months No
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