| CTRI Number |
CTRI/2023/07/055802 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Upper airway angle and glottic height in prediction of difficult laryngoscopy. |
|
Scientific Title of Study
|
Upper airway angle and glottic height in predicting difficult laryngoscopy. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC KMC MLR 05/2023/193 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandu Lakshmi Lavanya |
| Designation |
PG in MD anesthesia |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Department of Anesthesiology,
Kasturba medical college,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7989872734 |
| Fax |
|
| Email |
chandulavanya524@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Suresh YV |
| Designation |
Professor,MD anesthesia |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Department of Anesthesiology,
Kasturba medical college,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9845085108 |
| Fax |
|
| Email |
suresh.yv@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chandu Lakshmi Lavanya |
| Designation |
PG |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Department of Anesthesiology,
Kasturba medical college,
Mangalore
KARNATAKA
575001
India |
| Phone |
7989872734 |
| Fax |
|
| Email |
chandulavanya524@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college hospitals, mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba medical college hospital |
| Address |
Dakshina kannada, mangalore, karnataka -575001 |
| Type of Sponsor |
Private 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 lakshmi lavanya |
kasturba medical college |
Kasturba medical college, mangalore, dakshina kannada
Dakshina Kannada
KARNATAKA |
7989872734
Chandulavanya524@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgeries under general anesthesia
Patients of ASA 1-3 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Uncooperative patients
Patients having cervical spine fractures
Oral malignancy
Neck swelling and malignancy
Awake intubation
Edentulous patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Upper airway angle
Glottic height |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cormack lehanne grading
Ease of intubation
-no. Of attempts needed
-no. Of operators
-no. Of alternative techniques used
-external laryngeal pressure applied. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
05/08/2023 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Chandulavanya524@gmail.com].
- For how long will this data be available start date provided 30-11-2024 and end date provided 01-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This prospective analytical observational cross sectional study is to observe upper airway angle and glottic height to predict difficult laryngoscopy in patients undergoing elective surgeries under general anesthesia |