| CTRI Number |
CTRI/2025/09/095171 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two adjuncts to make endotracheal tube insertion easier when airway opening view is restricted |
|
Scientific Title of Study
|
Comparison of intubation characteristics of bougie versus stylet in simulated restricted glottic view during tracheal intubation with a hyper angulated non-channelled video laryngoscope in adults: A randomized controlled trial |
| 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 Devika C |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room 5011, 5th floor, Academic Block, AIIMS New Delhi 110029
Ansari nagar east 110029
New Delhi
DELHI
110029
India |
| Phone |
8921259624 |
| Fax |
|
| Email |
devika.c1110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riniki sarma |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 122, first floor , Trauma centre
AIIMS
Ansari nagar east 110029
New Delhi
DELHI
110029
India |
| Phone |
8447456976 |
| Fax |
|
| Email |
rinikirs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devika C |
| Designation |
Junior Resident |
| Affiliation |
Aiims |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room 5011, 5th floor, Academic Block, AIIMS New Delhi 110029
Ansari nagar east 110029
New Delhi
DELHI
110029
India |
| Phone |
8921259624 |
| Fax |
|
| Email |
devika.c1110@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS , New Delhi |
| Address |
AIIMS , NEW DELHI 110029, India |
| Type of Sponsor |
Government 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 Devika C |
All India Institute of Medical Sciences New Delhi |
Department of Anaesthesiology ,pain medicine and critical care , Room No 5011, 5th floor, Academic Block, AIIMS New Delhi 110029
New Delhi
DELHI |
8921259624
devika.c1110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims Institutional 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 characteristics with bougie |
bougie is used to rail road and secure an endotracheal tube while visualising the glottis with C-MAC D-Blade and intubation characteristics noted |
| Comparator Agent |
Intubation characteristics with Stylet |
stylet is used to secure an endotracheal tube while visualising the glottis with a C-MAC D-Blade and intubation characteristics notes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
EGRI less than 4
ASA physical status 1 and 2 requiring endotracheal intubation under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Condition requiring RSI
Pregnancy
Body mass index more than 40 kg per metre square
Need for non standard ETT
Known cervical myelopathy
Unsecured intracranial aneurysm
Uncontrolled hypertension
Coronary artery disease
Thyrotoxicosis
Phaeochromocytoma
Valvular hart disease
raised intracranial and intra ocular pressures
loose tooth and dental injury
suspected cervical spine injury and traumatic brain injury
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total time to intubation |
Post induction during intubation intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| first attempt success rate in each group |
Post induction during intubation intraoperatively |
| Ease of intubation |
Post induction during intubation intraoperatively |
| Number of optimisation maneuvers used like external laryngeal manipulation , repositioning |
Post induction during intubation intraoperatively |
| incidence of complications like airway trauma , desaturation, esophageal intubation |
Post induction during intubation intraoperatively |
| Failure rate with each adjunct |
Post induction during intubation intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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)
|
01/10/2025 |
| 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="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
|
This study is to be done in 146 patients who require endotracheal intubation under general anaesthesia. Each patient is intubated either with a endotracheal tube with stylet or bougie using a non channelled video laryngoscope and a hyper angulated blade to visualise the glottis . The glottis is visualised to a pogo score of less than 50 percent hence simulating a restricted glottic view in patient with normal airway that is EGRI score less than 4 .Total time to intubation , the first attempt success rate , the failure rate and the complications associated with both stylet and bougie is compared. |