| CTRI Number |
CTRI/2025/04/085150 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to measure and understand the defects in airways of old age patients with problems of ear, nose or throat, that might cause trouble in pre-operation procedures before and during anaesthesia. |
|
Scientific Title of Study
|
An observational study on the morphometric determinants of difficult laryngoscopy and intubation in geriatric patients with otolaryngological 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 SUJATA GHOSH |
| Designation |
Associate Professor |
| Affiliation |
R.G. KAR MEDICAL COLLEGE, KOLKATA |
| Address |
Department of Anaesthesia, 7th Floor, Emergency Building , R.G. Kar Medical College, 1, Khudiram Bose Sarani, Kolkata-700004, West Bengal, India.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9903663696 |
| Fax |
|
| Email |
dr.sujata444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BALADITTYA MAJHI |
| Designation |
UG Student, MBBS 2nd Prof |
| Affiliation |
R.G. KAR MEDICAL COLLEGE, KOLKATA |
| Address |
1, Khudiram Bose Sarani, Kolkata- 700004, West Bengal, India.
Kolkata
WEST BENGAL
700004
India |
| Phone |
8777350676 |
| Fax |
|
| Email |
baladittya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BALADITTYA MAJHI |
| Designation |
UG Student, MBBS 2nd Prof |
| Affiliation |
R.G. KAR MEDICAL COLLEGE, KOLKATA |
| Address |
1, Khudiram Bose Sarani, Kolkata- 700004, West Bengal, India.
Kolkata
WEST BENGAL
700004
India |
| Phone |
8777350676 |
| Fax |
|
| Email |
BALADITTYA@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi-110029, India. |
| R.G. Kar Medical College, 1, Khudiram Bose Sarani, Kolkata-700004, West Bengal, India. |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| RG KAR MEDICAL COLLEGE |
1, Khudiram Bose Sarani, Kolkata, 700004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujata Ghosh |
R.G. KAR MEDICAL COLLEGE |
ENT Operation Theatre, Department of Otolaryngology, Emergency building,
1, Khudiram Bose Sarani, Kolkata- 700004, West Bengal, India.
Kolkata
WEST BENGAL |
9903663696
dr.sujata444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RG Kar Medical College, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Geriatric population patients with otolaryngological problems is selected. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Morphometric evaluation of the airway to determine
difficult laryngoscopy. |
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predicting difficult airway in the Geriatric population. |
1 year
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
01/05/2025 |
| 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="0"
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 is instrumental in gaining exposure towards crucial anaesthesia procedures of laryngoscopy and intubation. This study shall provide insights in the variables related to geriatric patients with otolaryngological pathology that can affect judgement for successful and safe laryngoscopy and intubation during anaesthesia procedure in otolaryngological invasive procedures in the operation theatre. This study can provide with the validation of means for prediction of difficult laryngoscopy and intubation in geriatric otolaryngological patients, which will facilitate precaution steps for the procedure, resulting in reduced mortality of patients due to intubation failure in this population as well as aid to reduce physician’s stress resulting from such situations otherwise. |