CTRI

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CTRI Number

CTRI/2025/12/098409 [Registered on: 03/12/2025] Trial Registered Prospectively

Last Modified On:

03/12/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Study of neck soft tissue thickness preoperatively in patients undergoing elective surgery and correlation of laryngoscopy grades intraoperatively during intubation

Scientific Title of Study

Correlation of Ultrasound-Measured Anterior Neck Soft Tissue Thickness with Cormack–Lehane Laryngoscopic Grades During Endotracheal Intubation: A Cross-Sectional Observational Study”

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	SHREYA B S
Designation	Junior Resident
Affiliation	Sapthagiri Institute of Medical Sciences and Research Centre
Address	Anesthesia Department, Ground Floor, Sapthagiri Institute of MedicalSciences and Research Centre, Navy Layout, Hesaraghatta MainRoad, Chikkabanavara Anesthesia Department, Ground Floor, Sapthagiri Institute of MedicalSciences and Research Centre, Navy Layout, Hesaraghatta MainRoad, Chikkabanavara Bangalore KARNATAKA 560090 India
Phone	9591635025
Fax
Email	Shreyashetty6368@gmail.com

Details of Contact Person
Scientific Query

Name	MANJUNATH AC
Designation	MBBS, MD PROFESSOR OF ANESTHESIOLOGY
Affiliation	Sapthagiri Institute of Medical Sciences and Research Centre
Address	Anesthesia Department, Ground Floor, Sapthagiri Institute of MedicalSciences and Research Centre, Navy Layout, Hesaraghatta MainRoad, Chikkabanavara Anesthesia Department, Ground Floor, Sapthagiri Institute of MedicalSciences and Research Centre, Navy Layout, Hesaraghatta MainRoad, Chikkabanavara Bangalore KARNATAKA 560090 India
Phone	9591635025
Fax
Email	mac_acin@yahoo.co.in

Details of Contact Person
Public Query

Name	MANJUNATH AC
Designation	MBBS, MD PROFESSOR OF ANESTHESIOLOGY
Affiliation	Sapthagiri Institute of Medical Sciences and Research Centre
Address	Anesthesia Department, Ground Floor, Sapthagiri Institute of MedicalSciences and Research Centre, Navy Layout, Hesaraghatta MainRoad, Chikkabanavara Anesthesia Department, Ground Floor, Sapthagiri Institute of MedicalSciences and Research Centre, Navy Layout, Hesaraghatta MainRoad, Chikkabanavara Bangalore KARNATAKA 560090 India
Phone	9591635025
Fax
Email	mac_acin@yahoo.co.in

Source of Monetary or Material Support

Sapthagiri Institute of Medical Sciences and Research Centre Department of Anaesthesiology , Ground floor , OT Complex

Primary Sponsor

Name	Sapthagiri Institute of Medical Sciences and Research Centre
Address	Navy Layout, Hesaraghatta Main Road, Chikkabanavara
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Manjunath A C	Sapthagiri Institute of Medical Sciences and Research Centre	Anesthesia Department, Ground Floor, Sapthagiri Institute of MedicalSciences and Research Centre, Navy Layout, Hesaraghatta MainRoad, Chikkabanavara Bangalore KARNATAKA	8123540084 mac_acin@yahoo.co.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sapthagiri Institute of Medical Sciences and Research Centre	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy Human Volunteers undergoing elective surgery under general anaesthesia

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1)BODY MASS INDEX BETWEEN 18.5 TO 35Kg/m2 2) ABILITY TO GIVE VALID CONSENT 3) MALE AND FEMALE

ExclusionCriteria

Details

1)EMERGENCY SURGERIES
2)FACIAL,DENTAL AND NECK ABNORMALITIES
3)PREVIOUS SURGERIES IN THE NECK
4)PREGNANT WOMEN

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Correlation between ultrasound-measured anterior neck soft tissue thickness and Cormack–Lehane laryngoscopic grade during intubation Assessed intraoperatively	During intubation intraoperative for each patient(Single encounter)

Secondary Outcome

Outcome	TimePoints
Association between neck soft tissue thickness & ease of intubation.	During intubation intraoperative (single encounter)

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

15/12/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a cross-sectional observational study conducted to find the relationship between anterior neck soft tissue thickness measured by ultrasound and the Conmark Lehane grading seen during intubation. The study aims to determine whether ultrasound measurement of neck soft tissue can help predict difficult laryngoscopy in patients undergoing general anesthesia.