| CTRI Number |
CTRI/2025/07/090741 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Airway Devices used for intubation During General Anaesthesia in Adults patients |
|
Scientific Title of Study
|
Comparison of Fibreoptic guided tracheal intubation through Laryngeal mask airway Protector and Laryngeal mask airway
Blockbuster in adult patients in general anaesthesia - A Randomized Comparitive 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 |
Dr Aarth Aggarwal |
| Designation |
PG JR 1 |
| Affiliation |
Government Institute of Medical Science, Greater Noida |
| Address |
Dept of Anaesthesia
First floor Room no, 1001
Government Institute of Medical Science, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9310003199 |
| Fax |
|
| Email |
aarthagg1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Gupta |
| Designation |
Associate Professor Dept of Anaesthesia |
| Affiliation |
Government Institute of Medical Science, Greater Noida |
| Address |
Dept of Anaesthesia
First floor Room no, 2
Government Institute of Medical Science, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8750657382 |
| Fax |
|
| Email |
dr.gsavita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAARTH AGGARWAL |
| Designation |
PG JR 1 |
| Affiliation |
Government Institute of Medical Science, Greater Noida |
| Address |
Dept of Anaesthesia
First floor Room no, 1001
Government Institute of Medical Science, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9310003199 |
| Fax |
|
| Email |
aarthagg1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences |
| Address |
GIMS, Greater Noida
Gautam Buddha Nagar, Greater Noida, UP - 201310, 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 Aarth Aggarwal |
Government Institute of Medical Sciences |
Dept of Anaesthesia
First floor OT complex
Gautam Buddha Nagar
UTTAR PRADESH |
9310003199
aarthagg1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS Institutional Ethics Committee,Greater Noida |
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 |
Introduction of LMA blockbuster |
Following proper anaesthesia protocol and after taking consent from patient, patient will be intubated using LMA blockbuster. Patient will be observed for 24 hrs after extubation |
| Intervention |
Introduction of LMA protector |
Following proper anaesthesia protocol and after taking consent from patient, patient will be intubated using LMA Protector. Patient will be observed for 24 hrs after extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing elective surgery requiring GA with neuromuscular blockade ASA 1 AND ASA 2 grade patients having BMI 18-30 KG/M2 |
|
| ExclusionCriteria |
| Details |
Patients with known difficult airways (mouth opening less than 2.5cm, Mallampati class 3 and 4, cervical spine deformities, neck and jaw deformities).
BMI more than 30 Kg/m2
Patient with history of Gastro-oesophageal reflux disease
Pregnant females
Bleeding and clotting abnormalities
Patient with history of upper Gastrointestinal bleed
Patient getting operated for airway surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the time required for successful intubation through LARYNGEAL MASK AIRWAY Protector and LARYNGEAL MASK AIRWAY Blockbuster |
after Successful intubation i.e in minutes at 5 min, 10 min, 15 min, 20 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the number of attempts required for successful intubation in both groups |
maximum of two attempts will be allowed at 15 min, 20 min, 25 min
|
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
01/08/2025 |
| 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="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 - NO
|
|
Brief Summary
|
INTRODUCTION Maintenance of airway is an integral part of general anaesthesia. Various airway devices are used for this purpose. Endotracheal tube (ETT) is the gold standard for maintenance of airway . Second-generation supraglottic airway devices (SADs) are used for ventilation and as conduit for fiberoptic guided tracheal intubation (FGI). The supraglottic airway devices LARYNGEAL MASK AIRWAY BlockBuster and LARYNGEAL MASK AIRWAY Protector are improved second-generation LMAs with intubation function In the literature search, we did not find any report comparing the clinical performance of LARYNGEAL MASK AIRWAY Blockbuster with LARYNGEAL MASK AIRWAY Protector. Hence, the present study is planned to compare the clinical performance of these LMA’s in patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation OBJECTIVES
PRIMARY OBJECTIVES To compare the time required for successful intubation through LARYNGEAL MASK AIRWAY Protector and LARYNGEAL MASK AIRWAY Blockbuster (measured from picking up of the device to the appearance of the first capnography trace) SECONDARY OBJECTIVES To compare the number of attempts required for successful intubation in both groups 2. To compare the Grading of glottic view by Brimacombe and Berry scoring METHODOLOGY This study will be conducted in the Dept of Anaesthesiology , GIMS ,Greater Noida Adult patients of ASA I and II class undergoing elective surgery requiring general anaesthesia with neuromuscular blockade aged 18 to 65 years old having BMI of 18-35 Kg/M2
SAMPLE SIZE . Based on previous data, the mean time of insertion of the Laryngeal Mask Airway (LMA) was 12.2 seconds (SD = 1.5) in Group LB and 13.94 seconds (SD = 4.56) in Group LP, yielding an estimated effect size (Cohen’s d) of 0.5126. With a significance level of 0.05, desired power of 0.80, and an equal allocation ratio of 1:1 between the groups, the required total sample size was calculated to be 122 participants, with 61 participants in each group.
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