| CTRI Number |
CTRI/2025/09/094048 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two breathing devices mainly Blockbuster LMA and I-gel used during planned surgeries under general anesthesia, to see how well they work when patients head and neck are placed in different positions |
|
Scientific Title of Study
|
Comparison of two Supraglottic airway devices for efficacy of ventilation in different head and neck positions in patients undergoing elective surgery under general anesthesia |
| 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 Natasha Boro |
| Designation |
Post Graduate Resident |
| Affiliation |
VVMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Safdarjung Hospital Campus, Ansari Nagar West, Delhi
South West DELHI 110029 India |
| Phone |
8471979940 |
| Fax |
|
| Email |
tashaboro006@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nidhi Agrawal |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Safdarjung Hospital Campus, Ansari Nagar West, Delhi
South West DELHI 110029 India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nidhi Agrawal |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Safdarjung Hospital Campus, Ansari Nagar West, Delhi
South West DELHI 110029 India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi |
| 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 Natasha Boro |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anesthesiology and Intensive Care, Main OT building, ground floor, Safdarjung Hospital Campus, Ansari Nagar East South West DELHI |
8471979940
tashaboro006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Protocol Review 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 |
Blockbuster LMA for efficacy of ventilation in different head and neck positions in patients undergoing elective surgery under general anaesthesia |
Comparison of blockbuster LMA with i-gel for efficacy of ventilation in different head and neck positions of neutral, 20 degree flexion, maximum extension and maximum right lateral position in random order |
| Comparator Agent |
I-gel for efficacy of ventilation in different head and neck positions in patients undergoing elective surgery under general anesthesia |
Comparison of Blockbuster LMA with I-gel for efficacy of ventilation in different head and neck positions of neutral, flexion, extension and lateral rotation in patients undergoing elective surgery under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients in the age group of 18-65years of either gender belonging to ASA I-II undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway
2. Pathology of neck and cervical spine
3. Body mass index more than 35kg per meter square
4. Intrinsic lung disease
5. Patients at high risk of aspiration |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare oropharyngeal seal pressure of Blockbuster Laryngeal Mask Airway with i-gel in different head and neck positions in patients undergoing elective surgery under general anaesthesia |
Oropharyngeal seal pressure will be noted in neutral position and after 1 minute of each position change of head and neck such as 20 degree flexion, maximum extension and maximum right lateral position |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the following insertion characteristics of Blockbuster laryngeal mask airway with i-gel in patients undergoing elective surgery under general anaesthesia
1. Number of attempts taken for successful insertion of device
2. Time for achieving effective ventilation
3. Anatomical alignment of device with glottis opening ( Brimacombe score), Peak Inspiratory Pressure (PIP), Leak percent, OSP-PIP and ventilation score in different head and neck positions |
Each parameters will be noted in neutral position and after 1 minute of each position change of head and neck |
|
|
Target Sample Size
|
Total Sample Size="94" Sample Size from India="94"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="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
|
Supraglottic airway devices (SADs) are widely being used for airway management in patients undergoing elective surgery for offering safer alternative in terms of more hemodynamic stability and lesser postoperative respiratory complications as compared to endotracheal intubation. Securing airway during difficult airway scenario is a vital part for patient’s oxygenation and ventilation. SADs are being progressively redesigned to improve oropharyngeal seal pressure, semblance with airway anatomy for ease of device insertion and success rate for blind endotracheal intubation. Oropharyngeal seal pressure achieved by SADs holds due importance as it indicates the feasibility of positive pressure ventilation, the degree of airway protection from supra-cuff soiling and also relates to postoperative morbidity. Although, SADs are known to offer good seal, ventilation through SADs can be affected by change in head and neck positions required in various surgeries of head and neck for proper visualization of surgical field due to alteration of pharyngeal volume and shape. In this study we will compare Blockbuster Laryngeal Mask Airway with I-gel for efficacy of ventilation in different head and neck positions in patients of age group 18-65 years belonging to ASAI-II undergoing elective surgery under general anesthesia. The methodology and procedure of study will be explained to the patient and informed written consent will be taken. A computer generated random number table will be used to allocate patients in 2 groups ( group A and group B). Allocations will be concealed in sealed numbered opaque envelops, where group A represents Blockbuster LMA and group B represents i-gel. Patients will be taken to the operation theatre, monitors attached and baseline vitals noted. After preoxygenation with 100 percent oxygen, induction with inj. Fentanyl, inj. Propofol and muscle relaxant and IPPV for 3mins, group A will be intubated with Blockbuster LMA and group B with i-gel respectively. After confirmation of achieving effective ventilation, neutral position of head and neck will be made and parameters will be noted. Thereafter, the position of head and neck will be changed from neutral to 20 degree flexion, maximum extension and maximum right lateral position in random order and parameters will be noted in neutral position and after 1 minute of each position change of head and neck. Parameters to be noted are as follows 1. Number of attempts taken for successful insertion of device, time for achieving effective ventilation and ease of insertion of device 2. Oropharyngeal seal pressure (OSP), anatomical alignment of device with glottis opening (Brimacombe score), PIP, OSP-PIP, ventilation score and leak percent in neutral and different head and neck positions. |