NCT04711018

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 9, 2021

Last Update Submit

January 12, 2021

Conditions

Keywords

CephalometryEndotracheal intubationEthnicityLaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Difficult laryngoscopy

    Grade III or IV laryngeal view before endotracheal intubation

    Up to two weeks after preoperative examination

Study Arms (2)

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

LaryngoscopyDIAGNOSTIC_TEST

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.

Group DL (+)Group DL (-)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avcılar Murat Koluk State Hospital

Istanbul, 34320, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 16052126BACKGROUND
  • 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.

    PMID: 8638791BACKGROUND
  • 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.

    PMID: 23364566BACKGROUND
  • 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.

    PMID: 30630419BACKGROUND
  • 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.

  • 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.

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 9, 2021

First Posted

January 15, 2021

Study Start

February 1, 2020

Primary Completion

March 31, 2020

Study Completion

May 31, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations