| CTRI Number |
CTRI/2024/07/070864 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| 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
|
Comparing the Effectiveness of Two Preformed Supraglottic Airway Devices for Ventilation in Adult Patients During Elective Surgery Under General Anesthesia |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of Two Anatomically Preformed Supraglottic Airway Devices for Ventilation in Adult Patients Undergoing Elective Surgery Under General Anaesthesia |
| 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 Rahul Yadav |
| Designation |
PG Resident |
| Affiliation |
VMMC AND Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
India
South West
DELHI
110029
India |
| Phone |
8800876812 |
| Fax |
|
| Email |
rahulkush1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Agrawal |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC AND Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
India
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 and Consultant |
| Affiliation |
VMMC AND Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
India
South West
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VMMC AND Safdarjung Hospital |
| Address |
VMMC and Safdurjung Hospital |
| 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 Rahul Yadav |
VMMC and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Ground Floor, Main Operation Theatre Building, Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
India
South West
DELHI |
8800876812
rahulkush1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical college and Safdarjung Hospital, Institutional Ethics Committee IPRC |
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 |
Laryngeal Mask Airway Protector will have a better clinical efficacy for ventilation as compared
to BlockBuster Laryngeal Mask Airway in adult patients undergoing elective surgery under general anaesthesia |
Oropharyngeal leak pressure, Number of attempts taken for successful insertion of device, Time for achieving effective ventilation, Ease of insertion of device and gastric catheter,
Anatomical alignment of device with glottic opening
|
| Comparator Agent |
Oropharyngeal leak pressure of two different Laryngeal Mask Airway |
Compare oropharyngeal leak pressure of Laryngeal Mask Airway Protector with that of BlockBuster Laryngeal Mask Airway noted within 5 minutes of insertion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18-60 years, weighing 30-70 kg who meet the standards of
the American Society of
Anesthesiologists (ASA) grade I, II,
undergoing elective surgery under general anaesthesia with controlled ventilation
|
|
| ExclusionCriteria |
| Details |
1) Patients with anticipated difficult airway.
2) Body Mass Index more than 30kg/m2.
3) High risk of aspiration. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Laryngeal Mask Airway Protector will have a better clinical efficacy with that of
BlockBuster Laryngeal Mask Airway in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation. |
At Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare insertion characteristics of Laryngeal Mask Airway Protector with
BlockBuster Laryngeal Mask Airway |
At Base line |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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
Response - Clinical Study Report
- 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 [rahulkush1996@gmail.com].
- For how long will this data be available start date provided 09-11-2025 and end date provided 09-11-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The supraglottic airway devices (SADs) have been widely used as an alternative to tracheal
intubation during general anaesthesia or as an immediate life-saving measure in patients with
difficult or failed airway. Since the introduction of the Classic Laryngeal Mask Airway (LMA)by Dr. Archie brain, UK, several innovative supraglottic airway devices have been
developed. The second-generation SADs such as Laryngeal Mask Airway Proseal, Laryngeal
Mask Airway Supreme, LMA Protector and BlockBuster LMA integrate gastric drainage
tubes and improved airway seal, enhancing patient safety. LMA Protector and BlockBuster LMA can be used as conduit for blind endotracheal
intubation as they may help to tackle the “cannot ventilate cannot intubate " situation and can
be lifesaving in difficult airway situations. SADs with intubation conduit are also
recommended by All India Difficult Airway Association guidelines 2016 for difficult airway
situations. Laryngeal Mask Airway Protector (LMA-Protector) is a
new second generation supraglottic device made with medical-grade silicone. The LMA Protector provides access to, and functional separation of, the ventilation and digestive tracts,
with the presence of two drainage channels, which emerge proximally as separate ports and
enter a chamber, located behind the cuff bowl. BlockBuster LMA. It is an anatomically curved device made up of
silicone. It provides access to and functional separation of the ventilation and digestive tracts. We hypothesize that the LMA Protector will have a better clinical efficacy for ventilation as
compared to BlockBuster LMA in terms of higher oropharyngeal leak pressure in adult
patients undergoing elective surgery under general anaesthesia with controlled ventilation.
However, there is paucity of studies comparing the above two devices. Therefore we
designed this study to evaluate and compare the LMA Protector with BlockBuster LMA for
efficacy of ventilation in adult patients undergoing elective surgery under general anaesthesia
with controlled ventilation with the primary objective of comparison of oropharyngeal leak
(seal) pressure between the two devices |