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CompletedNCT04711018COMPAD-TUpdated Jan 15, 2021

Comparison of Various Measures for Anticipating Difficult Laryngoscopy

An observational study in Difficult Laryngoscopy, sponsored by Yedikule Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by Yedikule Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
145
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Difficult Laryngoscopy

Keywords

  • Cephalometry
  • Endotracheal intubation
  • Ethnicity
  • Laryngoscopy
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In context

Lead sponsor

Yedikule Training and Research Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • ASA I-II
  • Candidate for elective surgery under general anesthesia

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
145 participants (actual)
Patient registry
No

Groups and cohorts

  • Group DL (+)

    Grade III or IV laryngeal view according to Cormack-Lehane classification

    Diagnostic Test: Laryngoscopy

  • Group DL (-)

    Grade I or II laryngeal view according to Cormack-Lehane classification

    Diagnostic Test: Laryngoscopy

Interventions

  • Diagnostic testLaryngoscopy

    The laryngoscopy is performed with the help of an appropriate size Macintosh blade. The patient's head is held in the sniffing position. External manipulation is not used for improving the view in this investigation.

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What researchers measure

Primary outcomes

  1. Difficult laryngoscopy

    Grade III or IV laryngeal view before endotracheal intubation

    Time frame: Up to two weeks after preoperative examination

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Study locations

1 site
  • Avcılar Murat Koluk State Hospital
    Istanbul, 34320, Turkey
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References and documents

Publications

  • Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005 Aug;103(2):429-37. doi: 10.1097/00000542-200508000-00027. PubMed 16052126 ↗
  • el-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg. 1996 Jun;82(6):1197-204. doi: 10.1097/00000539-199606000-00017. PubMed 8638791 ↗
  • Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available. PubMed 23364566 ↗
  • Kim JC, Ki Y, Kim J, Ahn SW. Ethnic considerations in the upper lip bite test: the reliability and validity of the upper lip bite test in predicting difficult laryngoscopy in Koreans. BMC Anesthesiol. 2019 Jan 10;19(1):9. doi: 10.1186/s12871-018-0675-5. PubMed 30630419 ↗
  • Yildirim I, Inal MT, Memis D, Turan FN. Determining the Efficiency of Different Preoperative Difficult Intubation Tests on Patients Undergoing Caesarean Section. Balkan Med J. 2017 Sep 29;34(5):436-443. doi: 10.4274/balkanmedj.2016.0877. Epub 2017 Apr 13. PubMed 28443579 ↗
  • Selvi O, Kahraman T, Senturk O, Tulgar S, Serifsoy E, Ozer Z. Evaluation of the reliability of preoperative descriptive airway assessment tests in prediction of the Cormack-Lehane score: A prospective randomized clinical study. J Clin Anesth. 2017 Feb;36:21-26. doi: 10.1016/j.jclinane.2016.08.006. Epub 2016 Oct 31. PubMed 28183567 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04711018
Lead sponsor
Yedikule Training and Research Hospital
Collaborators
Avcılar Murat Koluk State Hospital
Responsible party
Derya Ozden Omaygenc (M.D., Haseki Training and Research Hospital) — Principal investigator
First posted
Jan 15, 2021
Start date
Feb 1, 2020
Primary completion
Mar 31, 2020
Completion
May 31, 2020
Last update
Jan 15, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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