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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  
MMC&RI,Mysore 
 
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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

 
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