NCT07668297

Brief Summary

The goal of this observational study is to evaluate thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL); to know which correlates better with the incisor vallecula distance (IVD). Based on the direction and strength of the correlation measure, a multiple regression equation can then be created to first predict the IVD with external linear measure, and second, based on IVD length prediction, the appropriate laryngoscope blade size can be ascertained.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Aug 2027

First Submitted

Initial submission to the registry

June 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 25, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 19, 2026

Last Update Submit

June 25, 2026

Conditions

Airway AssessmentLaryngoscopy

Keywords

Thyromental distanceMandibular triangle perpendicularLaryngoscopeincisor vallecula distance

Outcome Measures

Primary Outcomes (1)

  • Correlation of thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL) with incisor vallecular distance (IVD)

    In all patients thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL) will be measured. TMD will be measured as a straight line distance between the bony mentum (tip of the chin) and the superior thyroid notch (upper border of the thyroid cartilage). MTPL will be measured as the perpendicular of the mandibular triangle formed by joining the mental protuberence and point at angle of mandible on either side. During direct larygngosocpoy when the tip of the laryngoscope blade lies on the vallecula, the distance between the laryngoscope blade tip and the point of laryngoscope blade flange overlying the lower incisors will be measured. A correlation between TMD and MTPL with IVD if any will be established.

    From entry into preoperative area (0 minutes) to time patient is shifted to operating room ( 10-minutes)

Secondary Outcomes (2)

  • Correlation of incisor vallecular distance (IVD), mandibular triangle perpendicular length (MTPL), and thyromental distance (TMD) with Macintosh blade (MCB) size#3 length

    From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)

  • Cormack and Lehane score

    From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective surgery under general anaesthesia

You may qualify if:

  • Age 18-65 years
  • Males and females
  • ASA (American Society of Anaesthesiologists) physical status I and II
  • Patients scheduled for elective surgery with controlled ventilation through orotracheal tube conduit

You may not qualify if:

  • Smokers (those who have smoked ≥100 cigarettes in their lifetime), chewing tobacco dependence or substance abuse
  • Submucous fibrosis: progressive fibrosis of the submucosal tissue leading to rigidity, relative trismus, and progressive decrease of mouth opening
  • Anticipated difficult airway
  • Patients requiring intubation with MacIntosh blade #4 or #5
  • Dental issues:
  • missing tooth (upper/lower incisors, upper/lower premolar)
  • crowded dentition: - irregular, misaligned, or overlapping teeth within a relatively small oral cavity
  • presence of artificial teeth and/or dental implants
  • Mandible/mandibular structure related issues:
  • Retrognathia: - posterior displacement of the mandible relative to the maxilla or cranial base
  • Prognathia: - anterior displacement of the mandible relative to the maxilla or cranial base
  • Emergency Surgery
  • Those requiring urgent rapid-sequence intubation due to the presence of a full-stomach status secondary to gastro-esophageal reflux disease, diaphragmatic hernia, among others.
  • Refusal to informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

RECRUITING

Study Officials

  • Amitabh Dutta, MD

    Sir Ganga Ram Hospital, New Delhi-110060, India

    PRINCIPAL INVESTIGATOR

  • Paridhi Saboo, MBBS

    Sir Ganga Ram Hospital, New Delhi-110060, India

    PRINCIPAL INVESTIGATOR

  • Nitin Sethi, DNB

    Sir Ganga Ram Hospital, New Delhi-110060, India

    STUDY DIRECTOR

Central Study Contacts

Amitabh Dutta, MD

CONTACT

00919810848064duttaamitabh@yahoo.co.in

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 25, 2026

Study Start

June 25, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)