| CTRI Number |
CTRI/2024/06/069567 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
EVALUATE AND COMPARE VARIOUS DIFFICULT AIRWAY PARAMETERS IN OBESE PATIENTS, A PROSPECTIVE OBSERVATIONAL STUDY |
|
Scientific Title of Study
|
Evaluation and comparison of conventional difficult airway parameters and ultrasound guided parameters in obese patients undergoing general anesthesia; a prospective observational study |
| 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 SUNIL |
| Designation |
Resident |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Anaestesiology department
Sri Ramachandra medical College
Room no:G-123, Boys hostel,
Sri Ramachandra University
Porur,
Chennai-600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9489262930 |
| Fax |
|
| Email |
sunilraj616@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VENKATESH |
| Designation |
PROFESSOR |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Sri Ramachandra institute of Higher Education and Research Porur,
Chennai-600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9944731220 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUNL |
| Designation |
Resident |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Anaestesiology department
Sri Ramachandra medical College
Room no:G-123, Boys hostel,
Sri Ramachandra University
Porur,
Chennai-600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9489262930 |
| Fax |
|
| Email |
sunilraj616@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL,
PORUR,
CHENNAI 600116,
TAMIL NADU,
INDIA |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Sri Ramachandra University,
Porur,
Chennai-600116
Tamilnadu,
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SUNIL |
SR RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
OR complex,
Department of Anaesthesiology,
Porur,
Chennai-600116,
Thiruvallur
TAMIL NADU |
9489262930
sunilraj616@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH 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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient of either gender with BMI(Body mass index) between 30 to 40kg/m2 rquiring elective surgery under general anesthesia using endotracheal tube. |
|
| ExclusionCriteria |
| Details |
Need for awake fibreoptic intubation
Need for rapid sequence induction
Fascial abnormalities or lesion
Oral-Maxillilofascial surgeries
Parturients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Best predictive methods of assessment of difficult airway |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare & evaluate various conventional difficult airway parameters & ultrasound guided parameters |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Airway
assessment using ultrasound has recently been proposed as simply, non invasive,
bedside method as an adjunct to clinical evaluation.
Our study is to
evaluate and compare known conventional difficult airway parameters and
ultrasound guided parameters in obese patients and obtaining best predictive
method of difficult airway assessment.
|