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Clinical Trials/NCT04711018
NCT04711018CompletedNot Applicable

Comparison of Various Measures for Anticipating Difficult Laryngoscopy in Turkish Population: An Observational Study

Yedikule Training and Research Hospital1 site in 1 country145 target enrollmentStarted: February 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
145
Locations
1
Primary Endpoint
Difficult laryngoscopy

Study Overview

Brief Summary

Demographic features and eight diagnostic variables were evaluated for difficult laryngoscopy (DL) predictivity. These were retrognathia, presence of buck teeth, modified Mallampati test (MMT), upper lip bite test (ULBT), sternomental distance (SMD), interincisor distance (IID), thyromental distance, and neck circumference. DL was identified by Grade III-IV view during laryngoscopy according to the Cormack-Lehane (CL) classification.

Detailed Description

Creating a regression model among selected bedside tests for predicting difficult laryngoscopy )defined as Grade III or IV view during laryngoscopy according to Cormack-Lehane classification) is the primary objective. Recruiting of 145 ASA I-II adult patients who would have an elective surgery under general anesthesia were planned.

Criteria for exclusion were: a history of craniofacial surgery or restriction of cervical mobility, edentulous patients, pregnant women, patients who did not have a proper mouth opening (< 3 cm), and those who might require awake intubation or rapid sequence induction, cancellation of the surgery or change in the anesthetic strategy.

The selected tests and clinical situations were:

The presence of retrognathia (reduced temporomandibular joint-incisor distance) Buck teeth Modified Mallampati test (MMT) in the sitting position without phonation. A scale ranging between 1 and 4 points is used and scores of 3 or 4 are considered as predictors of DL. Upper lip bite test (ULBT) performed in a neutral position. ULBT is graded as 1-3 according to the extension ability of lower incisors.

Sternomental distance - The distance between the mentum and upper border of the manubrium sterni when the head is fully extended and the mouth is closed.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Candidate for elective surgery under general anesthesia

Exclusion Criteria

  • History of craniofacial surgery or restriction of cervical mobility,
  • Edentulous patients
  • Pregnancy
  • Patients who do not have a proper mouth opening (< 3 cm)
  • Patients who might require awake intubation or rapid sequence induction.

Outcomes

Primary Outcomes

Difficult laryngoscopy

Time Frame: Up to two weeks after preoperative examination

Grade III or IV laryngeal view before endotracheal intubation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Yedikule Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Derya Ozden Omaygenc

M.D.

Haseki Training and Research Hospital

Study Sites (1)

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