NCT05130645

Brief Summary

Airway management is extremely important for providing safe anesthesia. Endotracheal intubation, on the other hand, is the most important step in airway management, especially since it requires rapid and successful execution. Inadequate airway management; is associated with complications that require high-level care and cost, such as death, brain damage, increased need for intensive care, prolonged recovery period, and emergency tracheostomy. 15-25% of anesthesia-related deaths are associated with airway management. 17% of settled cases against anesthesiologists are composed of airway-related events (often difficult intubation, inadequate oxygenation/ventilation, and pulmonary aspiration). An important point in ensuring airway patency is preoperative evaluation. Difficulties arising from anatomical features can be revealed by careful evaluation of mouth opening, the structure of tongue and palate, thyromental distance (TMM), sternomental distance (SMM), mobility of cervical vertebrae, jaw occlusion, and necessary precautions can be taken. The most commonly used tests to determine the degree of difficulty of intubation are the modified Mallampati test, the thyromental distance, the upper lip bite test, the inter incisor space, and the sternomental distance. Recent studies are trying to confirm the sensitivity and specificity of existing tests. However, there is no test with 100% specificity and sensitivity in predicting difficult laryngoscopy and intubation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

November 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

November 11, 2021

Last Update Submit

November 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mandibular mental angle to predict the degree of difficulty in intubation

    The angle between the mentum of the mandibula and the lateral tips of the mandibula where the profiler ends

    5 min before intubation

  • Mandibular profile angle to predict the degree of difficulty in intubation

    "Mandibular mental angle" is defined as; the angle between the mentum of the mandibula and the two ends of the mandibular arch.

    5 min before intubation

Secondary Outcomes (7)

  • Cormack- Lehane grading system

    Procedure (During the use of direct laryngoscopy for intubation)

  • Modified Mallampati test

    5 min before intubation

  • Neck circumference

    5 min before intubation

  • Thyromental distance

    5 min before intubation

  • Sternomental distance

    5 min before intubation

  • +2 more secondary outcomes

Interventions

Mental AngleDIAGNOSTIC_TEST

In order to standardize and measure the mental angle, the projection of the mental will be accepted as the midline, the jaw structure will be transferred to the paper using the profile contour meter, and the angle between the angulus mandible and the mental will be measured and recorded with a digital protractor.

Also known as: Profiler Type Mental Angle

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who will operated under general anesthesia by endotracheal intubation

You may qualify if:

  • General Anesthesia
  • ASA I,II,III

You may not qualify if:

  • Patients with upper respiratory tract tumors
  • history of surgery, burns and trauma to the upper respiratory tract
  • congenital head-neck anomaly,
  • giant goiter, and
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Elif Şule Özdemir

    Diskapi Yildirim Beyazit ERH

    STUDY CHAIR

Central Study Contacts

Elif Şule Özdemir

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 23, 2021

Study Start

November 28, 2021

Primary Completion

March 20, 2022

Study Completion

April 20, 2022

Last Updated

December 9, 2021

Record last verified: 2021-11