| CTRI Number |
CTRI/2024/03/064792 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| 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
|
Comparison of Efficacy between Laryngeal Mask Airway Supreme and Blockbuster Laryngeal mask Airway in Different Head and Neck Positions |
|
Scientific Title of Study
|
Comparison of Oropharyngeal Leak Pressure between Laryngeal Mask Airway Supreme and Blockbuster Laryngeal Mask Airway in Different Head and Neck Positions: A Prospective, Comparative, Randomized 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 |
Riddhi Rajan |
| Designation |
PG Student in Anaesthesiology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra Institute of Higher Education and research,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7550065134 |
| Fax |
|
| Email |
m2322001@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akilandeswari |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra Institute of Higher Education and research,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840636238 |
| Fax |
|
| Email |
akilaanes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akilandeswari |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra Institute of Higher Education and research,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840636238 |
| Fax |
|
| Email |
akilaanes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Sri Ramachandra Higher Institute of Education and Research
|
| Principle Investigator |
|
|
Primary Sponsor
|
| Name |
Riddhi Rajan |
| Address |
Department of Anaesthesiology,
Sri Ramachandra Institute of Higher Education and research,
Porur, Chennai 600116 |
| 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 Riddhi Rajan |
Sri Ramachandra Institute of higher Education and research |
Department of Anesthesiology, No.1, Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU |
7550065134
m2322001@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRU |
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 Blockbuster |
Insertion of Laryngeal Mask Airway(LMA) Blockbuster and noting the Oropharyngeal Leak Pressure (OLP) in different head and neck postions for comparison .OLP will be determined by closing the expiratory valve of the circle system at a fresh gas flow of 3 l/min. The airway pressure will be permitted to increase until it reaches equilibrium (a maximum pressure of 40 cm H2O. The equilibrating airway pressure will be recorded when an audible leak occurs over the mouth. The leak pressure shall be recorded and documented at the following position - neutral, head extension-(45° from neutral), flexion (45° from neutral) in random order, followed by rotation to either side. The angle at each position is measured measured using a goniometer.
The patient head will then be placed in the neutral position and surgery will proceed, the LMA will be removed at the end of surgery when the patient is awake. |
| Comparator Agent |
Laryngeal Mask Airway Supreme |
Insertion of LMA Supreme,and determination of OLP in different head and neck positions. OLP will be determined by closing the expiratory valve of the circle system at a fresh gas flow of 3 l/min. The airway pressure will be permitted to increase until it reaches equilibrium (a maximum pressure of 40 cm H2O. The equilibrating airway pressure will be recorded when an audible leak occurs over the mouth. The leak pressure shall be recorded and documented at the following position - neutral, head extension-(45° from neutral), flexion (45° from neutral) in random order, followed by rotation to either side. The angle at each position is measured measured using a goniometer.
The patient head will then be placed in the neutral position and surgery will proceed, the LMA will be removed at the end of surgery when the patient is awake. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1-3
2. Elective surgeries of duration less than 3 hours
3. Any elective surgery requiring Laryngeal Mask Airway use
|
|
| ExclusionCriteria |
| Details |
BMI more than 35KG/M2
Pathology of neck such as cervical spondylosis Anticipated difficult airway
Risk of aspiration
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal leak Pressure with head in the neutral, flexed, extended and rotated to left position |
Immediately after insertion intraoperatively, within 30 mins of insertion of LMA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak airway pressure |
Immediately after insertion intraoperatively, within 30 mins of insertion of LMA |
| Expired tidal volume |
Immediately after insertion intraoperatively, within 30 mins of insertion of LMA |
| End tidal CO2 |
Immediately after insertion intraoperatively, within 30 mins of insertion of LMA |
| Difference between inspired & expired volume |
Immediately after insertion intraoperatively, within 30 mins of insertion of LMA |
| Difference between leak pressure & airway pressure |
Immediately after insertion intraoperatively, within 30 mins of insertion of LMA |
| Time to insert SAD |
From taking Laryngeal mask Airway in hand to Obtaining square shaped capnogram on the monitor,within 5 mins |
| successful placement in the first attempt |
During insertion, within first 5 mins |
| failed placement of SAD |
During Insertion, within first 10 mins |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/04/2024 |
| Date of Study Completion (India) |
04/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
second generation supraglottic
airways have become the standard
of care for positive pressure ventilation .
The leak pressures determine their efficacy for ventilation and
safety. The evaluation of leak pressures
in different head and neck position will
increase their clinical utility and avoid Endotracheal Tube placement for all surgeries involving changes in
head and neck position. The patient
shall benefit from smooth emergence, decreased requirement of narcotics and
anesthetic agents and avoids airway
instrumentation. |