CTRI Number |
CTRI/2022/07/044255 [Registered on: 22/07/2022] Trial Registered Prospectively |
Last Modified On: |
21/07/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Use of Baska mask versus Ambu-aura gain in adult patients undergoing elective surgery under general anaesthesia : A comparative study. |
Scientific Title of Study
|
A comparative study to assess the safety and efficacy of Baska mask versus Ambu-aura gain in adult patients undergoing elective surgery under general anaesthesia:A prospective randomized study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shalini A |
Designation |
Assistant Professor |
Affiliation |
Mysore medical college and research institute |
Address |
Department of Anaesthesiology
Mysore medical college and research institute,Mysore
Mysore KARNATAKA 570001 India |
Phone |
9986061614 |
Fax |
|
Email |
shalinianand20@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shalini A |
Designation |
Assistant Professor |
Affiliation |
Mysore medical college and research institute |
Address |
Department of Anaesthesiology, Mysore medical college and research institute, Mysore
Mysore KARNATAKA 570001 India |
Phone |
9986061614 |
Fax |
|
Email |
shalinianand20@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shalini A |
Designation |
Assistant Professor |
Affiliation |
Mysore medical college and research institute |
Address |
Department of Anaesthesiology, Mysore medical college and research institute, Mysore
Mysore KARNATAKA 570001 India |
Phone |
9986061614 |
Fax |
|
Email |
shalinianand20@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Dr Shalini A |
Address |
406,Bougain Villa,Sankalp Central Park, old jawa main road, Yadavagiri, Mysuru |
Type of Sponsor |
Other [Self, Primary investigator] |
|
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 Shalini A |
K R Hospital, MMC&RI |
Department of Anaesthesiology,Mysore Medical college and Research Institute,Mysore 570001 Mysore KARNATAKA |
9986061614
shalinianand20@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical committee,MMC&RI,Mysore |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Ambu -aura gain |
Control of airway using ambu-aura gain in adult patients subjected for general anaesthesia. |
Intervention |
Baska mask |
Control of airway using Baska mask in adult patients subjected to general anaesthesia. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Age group 18 – 60 years
2.ASA I and II
3.Patient who give valid informed written consent
4.Mallampati class 1 and 2
5.Patient undergoing elective surgeries under general anaesthesia with controlled ventilation
6.Duration of surgery <2 hours
|
|
ExclusionCriteria |
Details |
1.Age <18years and > 60 years
2.ASA grade III and above
3.Mallampati class 3 and above
4.Patients with systemic cardiovascular, respiratory, hepatic, renal or neurologic disorders
5.Emergency surgeries
6.Patients with decreased mouth opening
7.Patients with increased risk of aspiration
8.Patients with BMI > 30kg/m2
9.Patients with abnormal or distorted anatomy of oropharynx
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Oropharyngeal seal pressure
2. Ease of placement of device
3. Position of the ventilating orifice in relation to the larynx using fibreoptic bronchoscope.
4.Ease of removal of device
|
1. Oropharyngeal seal pressure
2. Ease of placement of device
3. Position of the ventilating orifice in relation to the larynx using fibreoptic bronchoscope.
4.Ease of removal of device
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Hemodynamic response, SpO2, EtCO2
2.Incidence of postoperative complications graded as mild, moderate and severe.
|
1.Hemodynamic parameters will be monitored in the following time interval-Basal before premedication, at the time of insertion,1 min,2 mins,5 minutes after insertion
and at the time of removal
,1 min and 5 mins after removal of the device.
2.Postoperative airway morbidities – sore throat, dysphagia, hoarseness of voice after 2hrs and 24hrs of surgery.
|
|
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
|
N/A |
Date of First Enrollment (India)
|
25/07/2022 |
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="0" Months="3" Days="15" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Publication of results of this study is planned. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Supraglottic airway (SGA) devices are used to
ventilate the patients by delivering gases above the level of vocal cords. Based on their different
sealing mechanisms and aspiration protection designs, SGA devices are broadly
classified into the first generation devices (inflatable cuff), second
generation (preshaped) and third generation devices (self energizing) as per
Miller’s new classification.
Ambu aura gain is a
second generation SGA made of polyvinyl chloride meant for single use with
preformed shape. It is the only anatomically curved SGA device with integrated
gastric access and also provides high sealing pressures that reduce the risk of
aspiration leading to higher safety level. It has bite block and
also a wider airway tube providing as an intubation conduit similar to Ambu
aura once and LMA proseal. Baska mask is a novel
third generation SGA made of medical grade silicone and available in four sizes
of 3, 4, 5 and 6 based on body weight. The characteristic feature of this mask is that
the airway pressure is transmitted intermittently to the flexile element of the
cuff so that it inflates and deflates with each positive pressure inspiration
and expiration respectively thus forming a perfect seal, reducing leaks and
making intermittent positive pressure ventilation very efficient. Many studies are
available comparing the efficiency of 3rd generation Baska mask with
various second generation SGA devices by various authors. Currently, there are no available studies that have compared the efficiency of
Ambu aura gain and Baska mask. Hence this prospective randomized comparative
study is being undertaken to compare the efficacy and safety between Ambu
aura gain and Baska mask as supraglottic airway device in adult patients
undergoing elective surgery under general anaesthesia. |