FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094920 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two bougies for airway management in Obese Patients Using a Video Laryngoscope  
Scientific Title of Study   Optimizing Tracheal Intubation in Obese Patients: A Randomized Trial of Standard Vs. Flexible Tip Bougies with Hyperangulated Videolaryngoscope  
Trial Acronym  comparing Bougies in Obese 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nishant Patel 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no. 5007, Teaching block, AIIMS,New Delhi

South
DELHI
110029
India 
Phone  8510955882  
Fax    
Email  pateldrnishant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nishant Patel 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no. 5007, Teaching block, AIIMS,New Delhi

South
DELHI
110029
India 
Phone  8510955882  
Fax    
Email  pateldrnishant@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nishant Patel 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no. 5007, Teaching block, AIIMS,New Delhi

South
DELHI
110029
India 
Phone  8510955882  
Fax    
Email  pateldrnishant@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New Delhi, India, Pincode-110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  All India Institute of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029  
Type of Sponsor  Research institution 
 
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 Nishant Patel   All India Institute of Medical Sciences New Delhi   Department of Anaesthesiology Pain Medicine and Critical Care, Ward Block, Ab8, 8th Floor, Main OT complex, Aiims, New Delhi, India
South
DELHI 
85109 55882

pateldrnishant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere, (2) ICD-10 Condition: E669||Obesity, unspecified, (3) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, (4) ICD-10 Condition: H719||Unspecified cholesteatoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Flexible tip bougie   Intubation will be done using CMAC D Blade with the help of Flexible tip bougie. 
Comparator Agent  Standard bougie   Intubation will be done using CMAC D Blade with the help of Standard bougie. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  BMI more than 30 and ASA 1-3. 
 
ExclusionCriteria 
Details  1.Mouth opening less than 2 fingers
2.
Emergency surgery
3.Nasal intubation & Awake tracheal intubation
4.Patient requiring rapid sequence intubation
5.Patient having intraoral tumors
6.Patient undergoing elective oral surgery such as micro laryngeal surgery, tonsillectomy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Modified intubation difficulty scale score   From anaesthesia induction to endotracheal intubation at 0 minutes, 5 minutes, 10 minutes, 15 minutes after intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Laryngoscopy time, First attempt intubation success rate, Number of intubations, Intubation difficulty scores, Incidence of failed intubation, Use of optimization manoeuvres, Heart rate (HR) & oxygen saturation trends during intubation, Complication-desaturation, dental trauma, oesophageal intubation
 
From anaesthesia induction to endotracheal intubation at 0 minutes, 5 minutes, 10 minutes, 15 minutes after intubation. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 4 
Date of First Enrollment (India)   29/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Obese patients present unique airway management challenges due to altered anatomy, leading to increased risk of difficult intubation and peri-intubation complications. Hyperangulated videolaryngoscopes (VLs) like the C-MAC D-Blade enhance glottic visualization but make tube insertion more challenging. This prospective randomized trial aims to compare the effectiveness of standard bougie versus flexible-tip bougie for tracheal intubation using a C-MAC D-Blade in obese adults. After preoperative evaluation and informed consent, eligible patients will be randomised into two groups: Standard Bougie group and Flexible-Tip Bougie group. Following standard general anesthesia induction and neuromuscular blockade, intubation will be performed in the ramped position using the assigned bougie technique. An experienced anesthesiologist will conduct all intubations. The primary outcome is the modified Intubation Difficulty Scale (mIDS) score. Secondary outcomes include intubation time, number of attempts, first attempt success rate, optimization maneuvers, and complications such as desaturation or dental trauma. This trial seeks to identify which bougie provides greater ease and success during tracheal intubation in obese surgical patients, thereby contributing to evidence-based airway management strategies.

 

 
Close