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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: difficult intubation
Intubation difficulty score >5
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.
Other: 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.
Other: Easy intubation
Intubation difficulty score >5
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trakya University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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