| CTRI Number |
CTRI/2024/07/071669 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial comparing the efficacy of two Supraglottic Airway Devices ie the Baska Mask versus the Proseal Laryngeal Mask Airway in patients undergoing elective surgeries under general anesthesia |
|
Scientific Title of Study
|
Efficacy of Baska Mask versus Proseal Laryngeal Mask Airway in elective surgeries under general anesthesia - a Randomized Controlled Trial |
| 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 R Ajisha Rachel |
| Designation |
Postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anesthesiology and Critical Care,
Sri Venkateshwaraa Medical College Hospital and Research Centre,
No.13-A,
Pondicherry-Villupuram Main Road,
Ariyur,
Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8903073058 |
| Fax |
|
| Email |
drajisharachel98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Krishnaprabu |
| Designation |
Professor and HOD |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anesthesiology and Critical Care,
Sri Venkateshwaraa Medical College Hospital and Research Centre,
No.13-A,
Pondicherry-Villupuram Main Road,
Ariyur,
Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Ajisha Rachel |
| Designation |
Postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anesthesiology and Critical Care,
Sri Venkateshwaraa Medical College Hospital and Research Centre,
No.13-A,
Pondicherry-Villupuram Main Road,
Ariyur,
Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8903073058 |
| Fax |
|
| Email |
drajisharachel98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College Hospital and Research Centre,
No.13-A, Pondicherry-Villupuram Main Road,
Ariyur,
Puducherry -605102
India. |
|
|
Primary Sponsor
|
| Name |
Dr. R. Ajisha Rachel |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre,
No 13-A, Pondicherry-Villupuram Main Road,
Ariyur,
Puducherry - 605102,
India. |
| Type of Sponsor |
Other [Self] |
|
|
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 R Ajisha Rachel |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
2nd Floor
Room No 1
Department of Anesthesiology and Critical Care
Pondicherry Villupuram Main Road
Ariyur
Puducherry 605102
Pondicherry
PONDICHERRY |
8903073058
drajisharachel98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supraglottic Airway Device (SAD) |
In Group A Proseal Laryngeal Mask Airway (PLMA) will be inserted and time taken for insertion,ease of insertion and number of attempts for insertion will be noted as well as the oropharyngeal seal pressure at 5 and 15 minutes post-insertion, as well as complications,if any. |
| Comparator Agent |
Supraglottic Airway Device (SAD) |
In Group B Baska Mask (BM) will be inserted and time taken for insertion,ease of insertion and number of attempts for insertion will be noted as well as the oropharyngeal seal pressure at 5 and 15 minutes post-insertion, as well as complications,if any.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, from 18 to 60 years of age, belonging to the American Society of Anesthesiologists (ASA) classes I, II and III. |
|
| ExclusionCriteria |
| Details |
Patients refusal,
BMI more than or equal to 30 kg per metre square,
Restricted mouth opening,
Surgeries lasting more than 2 hours,
Burns and swelling in neck,
High aspiration risk with poor pulmonary compliance
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure time taken for insertion, ease of insertion and number of attempts for insertion between the Proseal Laryngeal Mask Airway and the Baska Mask |
At start of insertion of both devices |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure oropharyngeal seal pressure (OSP) logged at two different times and post- insertion
complications between Baska Mask and Proseal Laryngeal Mask Airway
|
5 minutes and 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/08/2024 |
| 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 Applicable |
| 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 (SAD) have drastically changed the face of airway management
in patients undergoing anesthesia and have become a key component of modern airway
management, especially in surgeries of short durations. The Proseal Laryngeal Mask Airway (PLMA) is a reusable second generation SAD with an
additional inflatable dorsal cuff, integrated bite block, and a gastric drain tube, while the Baska Mask (BM), a third generation SAD, possesses newer modified features such as a sump with two drains and a bite block throughout the entire length of the
airway tube, which would lead to better clinical performance than the PLMA. This study aims to compare the advantages and efficacy of Baska Mask (BM) over Proseal Laryngeal Mask
Airway (PLMA) ) in adult patients undergoing elective surgery under general anesthesia with controlled
ventilation. |