| CTRI Number |
CTRI/2025/12/098788 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment of difficulty in intubation in 92 overweight patients in supine and 25 degree back up position on the operating table. |
|
Scientific Title of Study
|
Comparison of glottic views and difficulty in intubation in head elevated laryngoscopy position with overweight patients in supine and 25° backup: A Randomized Controlled 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 |
Akash N |
| Designation |
Post Graduate Resident |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
MSRIT Post Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9035371947 |
| Fax |
|
| Email |
akashn014@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prapti Rath |
| Designation |
Associate Professor , Department of Anaesthesiology , Ramaiah Medical College |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
MSRIT Post Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
8197007915 |
| Fax |
|
| Email |
praps1985@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Akash N |
| Designation |
Post Graduate Resident |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
MSRIT Post Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9035371947 |
| Fax |
|
| Email |
akashn014@gmail.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College
Bangalore 560054, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
New BEL Road MSRIT Post Bengaluru 560054 |
| 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 Akash N |
MS Ramaiah Medical College and Hospital |
Department of Anaesthesiology
MS Ramaiah Medical College Hospital
New BEL Road
Bangalore KARNATAKA |
9035371947
akashn014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College and Hospitals 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 |
Intubation |
46 Patients in 25 degree back up position over a course of 2 years. |
| Intervention |
Intubation |
46 Patients in supine position over a course of 2 years |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists(ASA) I and II
Mallampati grade more than 3
Body Mass Index more than 25 in both males and females
Elective surgeries requiring general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Cervical spine pathology
Aspiration risk
Rheumatoid Arthritis
Facial deformity
Emergency Surgeries
Rapid Sequence Intubation
Previous cervical surgeries
Neuromuscular disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the glottic view using Percentage Of Glottic Opening (POGO) and Cormack-Lehane(CL) grading in patients undergoing laryngoscopy in HELP with supine position versus HELP with 25° back-up positions. |
Inside the operating room at the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the time taken for intubation in both the groups.
2. To note the number of intubation attempts in both the groups. |
Inside the operating room at the time of intubation |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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)
|
07/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Obesity
is on the rising trend with a global estimate of 2.5 billion adults in the
recent years as per WHO survey. Number of obese patients undergoing elective
surgeries are increasing with each passing day, hence, the anesthetist
must be prepared to handle all peri operative care of these patients.
This
trend is associated with increased difficulty in airway management. In obese
patients, due to the anatomical and physiological changes, perioperative
complications are to be expected. Anatomical changes such as redundant upper
airway tissue, large tongue, and fat deposition in the neck complicate
laryngoscopy These factors hinder optimal positioning in the traditional
“sniffing the morning air” posture, prompting the exploration of alternative
techniques .
Proper
positioning of head and neck is important for optimizing glottic view which promotes the likelihood of successful intubation and decreases the number
of laryngoscopy attempts. Head-elevated and 25° back-up positions have emerged
as promising strategies to enhance glottic visualization, mask ventilation and
intubation success in this high-risk population consisting of patients with
obesity. |