| 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
|
|
|
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
|
|
|
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. |