| 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
|
|
|
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 |
|
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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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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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 |
|
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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:
- 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.
- 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.
- 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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