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CTRI Number  CTRI/2025/02/080862 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Doctors look at the neck shape and use X-rays or scans to see if there might be any problems when they try to use a special tool to look inside the throat This helps them prepare better for the procedure 
Scientific Title of Study   APPLICATION OF VARIOUS MORPHOLOGICAL AND RADIOLOGICAL PARAMETERS OF NECK IN PREDICTING DIFFICULTY IN DIRECT LARYNGOSCOPY PROCEDURE FOR GLOTTIC AND SUBGLOTTIC PATHOLOGY 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Somanath B Megalamani 
Designation  Professor and unit head 
Affiliation  Karnataka Medical College and Research Institute Hubballi Dharwad  
Address  Department of Otorhinolaryngology Karnataka Medical College and Research Institute Vidyanagar Hubballi Dharwad Karnataka 580021

Dharwad
KARNATAKA
580021
India 
Phone  9886276804  
Fax    
Email  somanathbm74@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Somanath B Megalamani 
Designation  Professor and unit head 
Affiliation  Karnataka Medical College and Research Institute Hubballi Dharwad  
Address  Department of Otorhinolaryngology Karnataka Medical College and Research Institute Vidyanagar Hubballi Dharwad Karnataka 580021

Dharwad
KARNATAKA
580021
India 
Phone  9886276804  
Fax    
Email  somanathbm74@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Somanath B Megalamani 
Designation  Professor and unit head 
Affiliation  Karnataka Medical College and Research Institute Hubballi Dharwad  
Address  Department of Otorhinolaryngology Karnataka Medical College and Research Institute Vidyanagar Hubballi Dharwad Karnataka 580021

Dharwad
KARNATAKA
580021
India 
Phone  9886276804  
Fax    
Email  somanathbm74@gmail.com  
 
Source of Monetary or Material Support  
Department of Otorhinolaryngology, KMCRI,Hubballi,Dharwad, Karnataka. 580021 
 
Primary Sponsor  
Name  Karnataka Medical College and Research Institute Hubballi  
Address  Vidyanagar Hubballi Dharwad Karnataka 580021 
Type of Sponsor  Government 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 Priyanka B K  Karnataka Medical College and Research Institute   Department of Otorhinolarngology, 302 ward, IP building, KMCRI, Hubballi, Dharwad, Karnataka 580021
Dharwad
KARNATAKA 
7996069810

priyankakalburgi14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karnataka Institute of Medical Science Hubballi ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All the patients with benign or malignant lesions of glottis and subglotttic region, scheduled for direct laryngoscopy procedure under general anaesthesia are included. 
 
ExclusionCriteria 
Details  1) Patients with known airway difficulty due to trauma and congenital abnormalities that compromise te airway.
2) Crritically ill patients in which airway assessment is difficult.
3) patients who do not give consent for the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To predict the difficulty in the direct laryngoscopy procedure based on morphological and radiological parameters of neck in the glottic and subglottic pathology  Measurements at preoperatively base line and intraoperative  
 
Secondary Outcome  
Outcome  TimePoints 
1)To analyse morphological parameters of neck & correlate their relation with difficulty score in the direct laryngoscopy procedure in glottic & sub glottic pathology.

2) To analyse radiological parameters of neck & correlate their relation with difficulty score in the direct laryngoscopy procedure in glottic & sub glottic pathology. 
Measurements at baseline preoperatively & intraoperative  
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   01/03/2025 
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 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  

This study aims to apply the various morphological and radiological parameters of neck in predicting difficulty in direct laryngoscopy procedure for glottic and sub glottic pathology. 


This study will be conducted at a teritiary care hospital in Karnataka institute of medical sciences, Hubballi, Karnataka, in the patients attending ENT department.


This is hospital based  observational study with total sample size of 72.


Patients belonging to all age groups with benign or malignant lesions of glottic and sub glottic region will be included in the study.

Patients with known difficult airway due to trauma and congenital abnormalities and critical ill patients and patients not giving consent for procedures are excluded.


Aim and objectives of this study includes:

  1. To analyse morphological parameters of neck and correlate their relation with difficulty score in the direct laryngoscopy procedure in the glottic and sub glottic pathology.
  2. To analyse radiological parameters of neck and correlate their relation with difficulty score in the direct laryngoscopy procedure in the glottic and sub glottic pathology.
  3. To predict the difficulty in direct laryngoscopy procedure based on the above data.


Methodology includes all patients satisfying inclusion criteria selected and informed consent taken.

Morphological and radiological parameters are measured, during preoperative evaluation.

Difficult laryngoscopy score is done, while doing direct laryngoscopy.

Data collected is entered into data sheet and analysed using s

SPSS IBM 22 version.

For qualitative data, test of significance chi square test is applied.

For quantitative data, t test will be used and if p value is less than 0.05 is considered to be significant.

Further results are concluded.


 
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