| CTRI Number |
CTRI/2026/01/102640 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare between ease of intubation by fiberoptic through I-gel vs blockbuster LMA |
|
Scientific Title of Study
|
A comparison of i-gel plus and blockbuster LMA as a conduit to fiberoptic guided intubation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yaduvendra |
| Designation |
Junior resident |
| Affiliation |
Pt. B.D Sharma PGIMS Rohtak |
| Address |
Department of anaesthesia and critical care, second floor new ot cum icu complex, second floor, Pt. B.D.Sharma PGIMS rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992984091 |
| Fax |
|
| Email |
yaduyrj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshul |
| Designation |
Associate professor |
| Affiliation |
Pt. B.D Sharma PGIMS Rohtak |
| Address |
Department of anaesthesia and critical care, second floor new ot cum icu complex, second floor, Pt. B.D.Sharma PGIMS rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9034552949 |
| Fax |
|
| Email |
Anshulpooja03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yaduvendra |
| Designation |
Junior resident |
| Affiliation |
Pt. B.D Sharma PGIMS Rohtak |
| Address |
Department of anaesthesia and critical care, second floor new ot cum icu complex, second floor, Pt. B.D.Sharma PGIMS rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992984091 |
| Fax |
|
| Email |
yaduyrj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS rohtak |
| Address |
Department of anaesthesia and critical care, second floor,modular Ot complex,Pt.B.D Sharma PGIMS rohtak |
| 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 Yaduvendra |
Pt. B.D. sharma, pgims rohtak |
Department of anaesthesia and critical care, second floor new ot complex, PGIMS rohtak
Rohtak
HARYANA |
9992984091
yaduyrj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee, PGIMS, ROHTAK |
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 |
| Comparator Agent |
Patient will be intubated through blockbuster LMA |
Patients who will be intubated through blockbuster LMA using fiberoptic |
| Intervention |
Patients who will be intubated through I-gel plus |
Patient will be intubated using fiberoptic through I-gel plus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18-60 years of either sex of ASA
grade I and II scheduled for elective surgery requiring general
anesthesia and endotracheal intubation will be included. |
|
| ExclusionCriteria |
| Details |
Patients having respiratory or oral pathology, mouth opening
Less than 2.0 cms, Body mass index greater than 30, pregnancy, full
stomach, suspected difficult airway will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective of the study is to evaluate the time taken to place the
endotracheal tube using i-gel Plus and Blockbuster LMA. |
total time taken to place the
endotracheal tube. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal leak pressure of supraglottic device |
After insertion of supraglottic device & before insertion of fiberoptic device |
| Time taken to place and ease of placement of the supraglottic device |
Time to noted in seconds after appropriate muscle relaxation is noted |
| The number of insertion attempts and ease of 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [yaduyrj@gmail.com].
- For how long will this data be available start date provided 31-12-2026 and end date provided 31-03-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective randomized study compares the i-gel Plus and Blockbuster laryngeal mask airway (LMA) as conduits for fiberoptic-guided tracheal intubation in adult patients undergoing elective surgery under general anesthesia. Eighty ASA I–II patients aged 18–60 years will be randomized into two equal groups to undergo fiberoptic intubation via either i-gel Plus or Blockbuster LMA. The primary outcome is the time taken for successful tracheal intubation. Secondary outcomes include oropharyngeal leak pressure, ease and time of device insertion, number of intubation attempts, ease of intubation, and incidence of adverse events. The study aims to identify the more efficient and safer intubating supraglottic airway device. |