| CTRI Number |
CTRI/2023/07/055262 [Registered on: 16/07/2023] Trial Registered Prospectively |
| Last Modified On: |
15/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting difficult intubation using El Ganzouri risk index |
|
Scientific Title of Study
|
Prediction of difficult videolaryngoscopy and intubation using El Ganzouri risk index in patient undergoing general anaesthesia. |
| 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. Yogita Anand |
| Designation |
Post graduate student |
| Affiliation |
VMMC and Safdarjung hospital |
| Address |
Department of Anesthesia, Ground floor main OT complex,Vardhman Mahavir college and Safdarjung hospital, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
Yogitanand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Madhu Dayal |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung hospital |
| Address |
Department of anesthesiology, main OT building ground floor, Vardhman Mahavir medical college and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
Drmadhudayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Madhu Dayal |
| Designation |
Professor and consultant |
| Affiliation |
VMMC and Safdarjung hospital |
| Address |
Department of anesthesiology, main OT building ground floor, Vardhman Mahavir medical college and Safdarjung hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9811271996 |
| Fax |
|
| Email |
drmadhudayal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
VMMC & Safdarjung hospital |
| Address |
East Ansari Nagar, New Delhi 110029 |
| 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 Yogita Anand |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of Anesthesiology , ground floor main OT complex
South
DELHI |
7042817975
Yogitanand@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Scheduled for plastic surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologists physical status one and two.
Scheduled for elective plastic surgery under general anaesthesia with oro tracheal intubation. |
|
| ExclusionCriteria |
| Details |
Patient requiring awake fibre optic intubation.
Patient requiring rapid sequence induction.
Patient having thyroid or neck swelling. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| El Ganzouri risk index score will be calculated and correlated with POGO score and difficulty in laryngoscopy |
At the time of laryngoscopy and intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlate El Ganzouri risk index with intubation difficulty score & cormack Lehane grade |
At the time of laryngoscopy & intubation |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
25/07/2023 |
| 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 - NO
|
|
Brief Summary
|
Study aims to predict difficult video laryngoscopy and intubation using El Ganzouri risk index in patients undergoing general anaesthesia and will include all adult patients between ages of 18 to 65 of ASA grade 1&2 scheduled for plastic surgery under general anaesthesia with oro tracheal intubation |