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CTRI Number  CTRI/2023/01/048788 [Registered on: 06/01/2023] Trial Registered Prospectively
Last Modified On: 05/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To compare the effectiveness of two different types of tubes  
Scientific Title of Study   Comparative evaluation of ambu aura-I and fastrachTM intubating laryngeal mask airway for tracheal intubation: A Randomized controlled 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 RAVI M 
Designation  PROFESSOR AND HOD 
Affiliation  Sri Devaraj urs medical college 
Address  DEPARTMENT OF ANAESTHESIA, SRI DEVRAJ URS MEDICAL COLLEGE, TAMAKA, KOLAR
Sri Devaraj Urs Medical College Tamaka, Kolar
Kolar
KARNATAKA
563101
India 
Phone  9845287591  
Fax    
Email  ravijaggu@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RAVI MADHUSUDHANA 
Designation  HOD- PROFESSOR 
Affiliation  Sri Devaraj urs medical college 
Address  Department of Anaesthesia, Sri Devaraj Urs Medical College Tamaka, Kolar
Sri Devaraj Urs Medical College Tamaka, Kolar
Kolar
KARNATAKA
563101
India 
Phone  9845287591  
Fax    
Email  ravijaggu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S M Kushal 
Designation  First year postgraduate  
Affiliation  Sri Devaraj urs medical college 
Address  DEPARTMENT OF ANAESTHESIA, SRI DEVRAJ URS MEDICAL COLLEGE, TAMAKA, KOLAR
Sri Devaraj Urs Medical College Tamaka, Kolar
Kolar
KARNATAKA
563101
India 
Phone  7760505880  
Fax    
Email  dr.smkushal@gmail.com  
 
Source of Monetary or Material Support  
S M Kushal Study conducted in Sri Devaraj urs Medical college, Tamaka,Kolar 
 
Primary Sponsor  
Name  S M Kushal 
Address  Sri Devaraj Urs medical college Tamaka, Kolar 
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Ravi Madhusudhana  RL Jalappa Hospital  Department of Anesthesia, Sri Devaraj Urs Medical College Tamaka, Kolar
Kolar
KARNATAKA 		 9845287591

ravijaggu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ambu Aura i and FastrachTM intubating laryngeal mask airway  Comparing the effectiveness of ambu aura i and FastrachTM intubating laryngeal mask airway. Duration- 5minutes 
Intervention  Ambura Aura i and Fastrach TM intubating laryngeal mask airway  Intubating LMA will be introduced first and then Normal ET tube will be passed through the LMA and the LMA will be removed. Duration-5 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  · Age 18 to 60 years
· ASA 1 and 2
 
 
ExclusionCriteria 
Details  · Younger than 18 years old
· American Society of Anaesthesiologists physical status IV or V
· Diagnosed with respiratory tract pathology or coagulation disorders requiring a nasal route for tracheal intubation
· Those at risk of regurgitation–aspiration (previous upper gastrointestinal tract surgery, known hiatus hernia, esophageal reflux, peptic ulceration, or not fasted).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate the effectiveness of intubation with Fastrach TM LMA and Ambu aura-i in Anticipated Difficult Airway Management

2) To evaluate the time taken and number of attempts for intubation with FastrachTM and Ambu Aura-i in Anticipated Difficult Airway Management.
 		 18 months

 
 
Secondary Outcome  
Outcome  TimePoints 
FastrachTM intubating LMA is better than Ambu aura-i LMA  18 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   09/01/2023 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Supraglottic airway devices (SADs) play a critical role in the airway management.
In any situation where intubation cant be done, the American Society of Anesthesiologists (ASA), Difficult Airway Society (DAS), and Obstetric Anaesthetists’ Association and DAS guidelines recommends the use of SADs as conduit for tracheal intubation.
The FastrachTM-laryngeal mask airway was designed to provide both ventilation and ability to pass a tracheal tube blindly into the trachea.
The Ambu Aura‐i is single‐use intubating SAD, also designed for both ventilation and as a conduit for tracheal intubation.

After extensive research on the literature, it is found that there is not enough data available on the tracheal intubation assessment with Ambu Aura-i. Hence, the present study will be done to compare the tracheal intubation using FT‐LMA and Aura‐i in adults.

 
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