NCT02814266

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

June 14, 2016

Last Update Submit

June 22, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Goniomastoid distance

    5 months

Study Arms (2)

difficult intubation

OTHER

Intubation difficulty score \>5

Other: difficult intubationOther: easy intubation

Easy intubation

OTHER

Intubation difficulty score \>5

Other: difficult intubationOther: easy intubation

Interventions

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 intubationdifficult 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 intubationdifficult intubation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing abdominal surgery with general anesthesia
  • Able to sit

You may not qualify if:

  • Enable to sit,
  • Patients had head or neck surgery,
  • Patients with unstable cardiological and respiratory hemodynamic symptoms,
  • Dental prosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assoc Professor

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 27, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share