| CTRI Number |
CTRI/2024/08/072295 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Medical Device Anaesthesia] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare of efficacy of two single use supraglottic airway devices for ventilation in adult patients undergoing elective surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of efficacy of two single use supraglottic airway devices for ventilation in adult patients undergoing elective surgery under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manu Kumar Singh |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anesthesia and Intensive care, ground floor, main operation theatre building, safdarjung hospital campus, Ansari Nagar East, New Delhi, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9318311692 |
| Fax |
|
| Email |
imanu2805@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 East, New Delhi
New Delhi
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 East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and critical care, VMMC and Safdarjung Hospital, New Delhi, PIN code-110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung hospital New Delhi |
| Address |
Department of Anaesthesia and critical care, safdarjung Hospital, 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 Manu Kumar Singh |
VMMC & Safdarjung hospital |
Department of Anesthesia and Intensive care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi
New Delhi
DELHI |
9318311692
imanu2805@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government of India, Ministry of health and Family Welfare, Vardhman Mahavir Medical College and Safdarjung hospital, New Delhi, 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 |
| Comparator Agent |
To compare efficacy of BlockBuster Laryngeal Mask Airway for ventilation with that of Ambu AuraGain in adult patients. |
To compare efficacy of BlockBuster Laryngeal Mask Airway for ventilation with that of Ambu AuraGain in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation. |
| Intervention |
To compare efficacy of two single use supraglottic airway devices for ventilation in adult patients undergoing elective surgery under general anaesthesia. |
To compare oropharyngeal leak pressure of BlockBuster Laryngeal Mask Airway and Ambu AuraGain. The duration can vary from 1-4 hours as required for the elective surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group 18-60 years.
2) weight 30-70 kgs.
3) ASA grade 1 and 2. |
|
| 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 |
| To compare efficacy of BlockBuster Laryngeal Mask Airway for ventilation with that of Ambu AuraGain in adult patients. |
At base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare insertion characteristics of BlockBuster Laryngeal Mask Airway & Ambu AuraGain. |
At base line |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/08/2024 |
| 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 - NO
|
|
Brief Summary
|
The supraglottic airway devices(SADs) are commonly used for airway management during anaesthesia or as an immediate life-saving measure in patients with difficult or failed airway. The second generation SADs make two separate seals with respiratory and gastrointestinal tracts to reduce risk of pulmonary aspiration. Ambu AuraGain is a newer single use anatomically curved supraglottic airway device with a gastric conduit and intubation capability. The integrated gastric access channel is designed with a low friction inner surface to facilitate easy placement of a gastric tube. BlockBuster Laryngeal Mask Airway has a short airway tube which has angulation to match the oropharyngeal curve and thus makes the insertion easy and less traumatic. It also has a gastric conduit and intubation capability. It has a guidance device which directs the tracheal tube towards the laryngeal opening at an angle of 30 degrees which enhances rate of successful blind intubation. The subjects are divided into 2 groups ( group A- Ambu AuraGain inserted and group B- BlockBuster LMA inserted) using block randomisation and allotted into 1 of the 2 groups. We hypothesize that Ambu AuraGain has better efficacy for ventilation as compared to BlockBuster LMA in terms of oropharyngeal leak pressure in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation. |