FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080546 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Neck Circumference to Thyromental Distance Ratio: A Novel Predictor of Difficult Intubation in Non-Obese Patients 
Scientific Title of Study   Correlation of ratio of neck circumference to thyromental distance for predicting difficult intubation in non obese patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jigyasa Tigga 
Designation  Junior Resident  
Affiliation  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Rajnandgaon Chhattisgarh  
Address  Department of Anesthesiology, 4th floor, room no. 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon Chhattisgarh

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9407648990  
Fax    
Email  rupaljigyasa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smriti Bandhu  
Designation  Associate Professor  
Affiliation  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon  
Address  Department of Anesthesiology, 4th floor, room no. 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon Chhattisgarh

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7000562486  
Fax    
Email  drsmriti19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smriti Bandhu  
Designation  Associate Professor  
Affiliation  Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon  
Address  Department of Anesthesiology, 4th floor, room no. 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon Chhattisgarh

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7000562486  
Fax    
Email  drsmriti19@gmail.com  
 
Source of Monetary or Material Support  
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon Chhattisgarh India 491441 
 
Primary Sponsor  
Name  Jigyasa Tigga  
Address  Department of Anesthesiology, 4th floor, room no. 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon Chhattisgarh 
Type of Sponsor  Other [Self] 
 
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 Jigyasa Tigga   Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College and Hospital Rajnandgaon   Department of Anesthesiology, 4th floor, room no. 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon Chhattisgarh
Rajnandgaon
CHHATTISGARH 
9407648990

rupaljigyasa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College Pendri Rajnandgaon Chhattisgarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , , (1) ICD-10 Condition: Z682||Body mass index (BMI) 20-29, adult,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age Greater than 18 years
ASA class I, II, III
Body mass index- 18.5kg/m2-30kg/m2 
 
ExclusionCriteria 
Details  Age below 18 years
Refusal to participate
Edentulous patients
Pregnant
Midline neck swelling
Patient requiring rapid sequence induction or awake intubation
Morbid Obesity
Patients with burns, radiation of upper airway.
Congenital anomaly of Head and Neck.
MPG grade III or IV.
Cervical spondylitis.
Morbid Obesity BMI greater than 40kg/m2 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of difficult intubation in non obese patient.  Proper insertion of the tracheal tube with conventional laryngoscopy required not more than 3 attempts or more than 10 minutes. "ASA- Difficult Endotracheal Intubation". 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the correlation between the (NC/TM distance ratio) for determining intubation difficult score in patient undergoing general anesthesia.  1 year 2 months  
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   18/02/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   I want to conduct an observational study to "correlate the ratio of neck circumference to thyromental distance for predicting difficult intubation in non obese patients" for my MD Anesthesia Thesis.

Aim:- This study aims to assess the ability to predict and evaluate the risk of difficult endotracheal intubation using neck circumference to thyromental distance ratio in non obese patients undergoing surgical procedure.

Objective:- To determine a sensitive reliable specific predictor for difficult to intubation preoperatively.
1. To determine the incidence of difficult intubation in non obese patients.
2. To assess the correlation between the NC/ TM distance ration for determining intubation difficult score in patient undergoing general anesthesia.

Details of the study 

Study Design- Prospective Observational study.
Study Place- Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College and Hospital Rajnandgaon Chhattisgarh.
STUDY APPROVAL: Institutional Scientific and Ethics Committee.
STUDY DURATION: 01/04/2024 to 01/06/2025
STUDY POPULATION: Non obese patient scheduled for major surgeries under general anesthesia.
DATA COLLECTION: Preformed Pretested Proforma.

METHODOLOGY: This prospective observational study aims to investigate the correlation b/w the ration of NC/TM ratio and the difficulty of intubation in non-obese patients undergoing general anesthesia.
ETHICAL CONSIDERATIONS: This study will be conducted after obtaining approval from the institutional scientific and ethics committee.
Informed written consent will be obtained from all participating patients.
DATA COLLECTION: 
Preoperative assessment- Demographic data, BMI, height, and airway assessment variables will be recorded:
NC- measured at the level of cricoid cartilage.
TM- measured from the thyroid notch to the mentum with the neck fully extended.
Interimcisor Gap-  measured with maximum mouth opening.
Mallampati Score- classified into four grades based on the visibility of oral structure.

Intraoperative assessment- 
Intubation difficulty will be assessed using the intubation difficulty scale (IDS), which includes seven variables:
- Number of intubation attempts
- Number of additional operators
- Number of alternative intubation techniques used 
- Laryngoscopic view ( Cormack and Lehane grade)
- Lifting force applied during laryngoscopy 
-Need for external laryngeal pressure 
- Position of the vocal cords at intubation 
- A total IDS score will be calculated, with scores ≥5 indicating difficult intubation.
- Standard anesthesia monitoring will be implemented.
- After preoxygenation, general anesthesia will be induced.
- Laryngoscopy will be performed by an independent Anesthetist using a Macintosh laryngoscope. Laryngoscopy will be performed by senior contestant who has atleast five years of experience or trainee doctor who has 2 years of experience.

BURP maneuver ( Backward, Upward, Rightward Pressure) may be used to improve glottic visualisation.
The NC/TM ratio will be calculated, with a cutoff point of ≥5.0 for predicting difficult intubation.

STATISTICAL ANALYSIS 
The relationship b/w the NC/TM ratio and the IDS will be analysed to determine the predictive value of the NC/TM ratio for difficult intubation in non-obese patients.
This study will provide valuable insights into clinical utility of the NC/TM ratio as a predictor of difficult intubation, potentially aiding in the identification of patients at increased risk guiding the choice of airway management strategies.



 
Close