| CTRI Number |
CTRI/2023/12/060652 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
07/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using ultrasound to identify difficult airway in obese patient before surgery |
|
Scientific Title of Study
|
Ultrasonography as a screening test to predict difficult airway in obese adult patient : A cross-sectional study in a tertiary care center in Chengalpattu district
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritesh Kumar Panda |
| Designation |
Junior Resident |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology,Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai,Nellikupam,Kancheepuram District
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7008449031 |
| Fax |
|
| Email |
pandark20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Narayanan S |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology,Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai,Nellikupam,Kancheepuram District
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
944877188 |
| Fax |
|
| Email |
dr.vijay@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Ritesh Kumar Panda |
| Designation |
Junior Resident |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology,Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai,Nellikupam,Kancheepuram District
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7008449031 |
| Fax |
|
| Email |
pandark20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Shri Sathya Sai Medical College and Research Institute, Nellikupam,Thirporur_Guduvanchy Main Road,kancheepuram District,Tamilnadu,Pin-603108 |
|
|
Primary Sponsor
|
| Name |
RITESH KUMAR PANDA |
| Address |
Boys Hostel(Room Number-11,3rd Floor),Shri Sathya Sai Medical College and Research Institute, Nellikupam,Thirporur_Guduvanchy Main Road,kancheepuram District,Tamilnadu,Pin-603108 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ritesh Kumar Panda |
Shri Sathya Sai Medical College and Research institute |
Department of Anaesthesiology, Second Floor OT complex,Shri Sathya Sai Medical College and Research Institute, Nellikupam,Thirporur_Guduvanchy Main Road,kancheepuram District,Tamilnadu,Pin-603108
Kancheepuram
TAMIL NADU |
7008449031
pandark20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patient Posted for elective surgery under General
endotracheal anaesthesia.
-Adult (Age 18-60years)
-Body mass index(30-35kg/m2)
-Americal society of Anaesthesiology (ASA) grade I,II
|
|
| ExclusionCriteria |
| Details |
-Emergency Cases
-Pregnancy
-Renal Failure
-Poor Cardio Pulmonary Reserve
-Patient with Fracture Nasal bone, Fracture base of skull
-Preexisting airway malformation like cervical tumors or goiter
-American society of Anaesthesiology (ASA) grade - III, IV, V
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To determine diagnostic accuracy of Ultrasonography based on the Cormack-Lehane grading in Predicting difficult airway in obese adult Patient.
|
Preoperative period and Intraoperative period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine sensitivity, specificity, positive predictive value & negative predictive value of Ultrasonography in predicting difficult airway assessment with parameter Skin to Epiglottis. |
Pre operative & Intra Operative period |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
27/12/2023 |
| 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
|
Title
of the study:
ULTRASONOGRAPHY AS A SCREENING TEST TO PREDICT
DIFFICULT AIRWAY IN OBESE ADULT PATIENT: A CROSS-SECTIONAL STUDY IN A TERTIARY
CARE CENTER IN CHENGALPATTU DISTRICT Objective(s): PRIMARY- •
To determine diagnostic
accuracy of Ultrasonography based on the Cormack-Lehane grading in Predicting
difficult airway in obese adult Patient. SECONDARY- •
To determine sensitivity, specificity, positive predictive
value and negative predictive value of Ultrasonography in predicting difficult
airway assessment with parameter Skin to Epiglottis.
|