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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Approved/Obtained 
 
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.

 
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