Clinical trial NCT04711018: Comparison of Various Measures for Anticipating Difficult Laryngoscopy
Official title: Comparison of Various Measures for Anticipating Difficult Laryngoscopy in Turkish Population: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Laryngoscopy
Keywords: Cephalometry
Endotracheal intubation
Ethnicity
Laryngoscopy
Lead sponsor: Yedikule Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Avcılar Murat Koluk State Hospital
First posted: 2021-01-15
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients attending the anesthesiology out-patient clinic for preoperative evaluation in Kanuni Sultan Suleyman Ed. ad Research Hospital. The planned anesthetic method should be general anesthesia.

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.

Thyromental distance (TMD) - The distance between mentum and the thyroid notch when the head is fully extended.

Interincisor distance (IID) - The distance between upper and lower incisors when the mouth is fully opened.

Neck circumference (NC) - It was measured at the level of the cricoid cartilage, perpendicular to the cervical axis.

The patients are premedicated with 0.03 mg/kg and oxygenated with the help of a bag-mask. Anesthesia is induced by consequent administration of 2 mcg/kg fentanyl, 1 mg/kg lidocaine, 2 mg/kg propofol, and 0.7 mg/kg rocuronium bromide thereafter. Two minutes after induction, the laryngoscopy is performed

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* 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.

Primary outcomes:
measure: Difficult laryngoscopy
timeFrame: Up to two weeks after preoperative examination
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Avcılar Murat Koluk State Hospital
Study officials:
References:
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