FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/05/019126 [Registered on: 14/05/2019] Trial Registered Prospectively
Last Modified On: 09/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of the clinical performance of I gel and Ambu Aura Gain supra glottic airway devices in paediatric patients under controlled ventilation. 
Scientific Title of Study   Comparison of the clinical performance of I-gel and Ambu Aura Gain -supra-glottic airway devices in paediatric patients under controlled ventilation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashka V Surve 
Designation  Second Year Resident 
Affiliation  Government Medical College and SSG Hospital Vadodara 
Address  303-TOWER 2/A, NATRAJ ENCLAVE, RBG COMPLEX, JALARAM TEMPLE RD KARELIBAUG 390018
Department of anesthesiology, ssg hospital , jail road, baroda.
Vadodara
GUJARAT
390018
India 
Phone  9033694150  
Fax    
Email  ashkasurve@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Patel 
Designation  Assocoate Professor 
Affiliation  Government Medical College and SSG Hospital Vadodara 
Address  Government Medical College and SSG Hospital, jail road, beside police bhavan, Vadodara

Vadodara
GUJARAT
390018
India 
Phone  9825453024  
Fax    
Email  mgpatel111@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Ashka V Surve 
Designation  Second Year Resident 
Affiliation  Government Medical College and SSG Hospital Vadodara 
Address  303-Tower 2/A, Natraj Enclave, RBG Complex, Beside Jalaram Temple Karelibaug, vadodara, 390018

Vadodara
GUJARAT
390018
India 
Phone  9033694150  
Fax    
Email  ashkasurve@gmail.com  
 
Source of Monetary or Material Support  
SSG hoapital and medical college, baroda, jail road, beside police bhavan, vadodara. 
 
Primary Sponsor  
Name  Ashka V Surve 
Address  303, Tower 2A, Natraj Enclave, RBG complex, Jalaram Temple Road, Karelibaug , Vadodara. 
Type of Sponsor  Other [self money] 
 
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 
ashka surve  SSG Hospital and GOvernment Medical COllege Baroda  SSG Hospital and Government Medical College , Jail Road, Beside Police Bhavan, Vadodara.
Vadodara
GUJARAT 		 9033694150

ashkasurve@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research Medical College and SSG Hospital Baroda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: L029||Cutaneous abscess, furuncle and carbuncle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ambu Aura Gain  Ambu Aura family of Supra-glottic Airway Devices contains various airways. The first generation devices among them are Ambu Aura Once, Ambu Aura Straight, Ambu Aura Flex, Ambu Aura I, Ambu Aura 40. The Ambu AuraGain is made of PVC material. The second generation device is Ambu Aura Gain with gastric access. It is anatomically curved supra-glottic airway device with integrated gastric access and intubation capability. It is designed to conform to the contours of the hypopharynx with its lumen facing the laryngeal opening. When correctly inserted, the distal tip of the cuff rests against the upper oesophageal sphincter. Its original anatomical curve follows the anatomy of human airway and the soft rounded curve ensures rapid placement and long term performance.  
Comparator Agent  I-gel   • I-gel was launched in 2007 after years of extensive research and development, I-gel now has an established reputation in anesthesia and it can be used safely and effectively for airway management under controlled ventilation in pediatric patients. • The soft non inflatable cuff is also designed that it matches the peri laryngeal anatomy. The device has buccal cavity stabilizer which has propensity to adopt its shape to oropharyngeal curvature of the patients. It is anatomically widened and concaved to eliminate the potential for rotation, thereby reducing the risk of malposition. This buccal cavity stabilizer houses airway tubing and separate gastric channel. The tube section is firmer than the soft bowl of the gastric channel. The firmness of tube section and its natural oropharyngeal curvature allows the device to be inserted by grasping the proximal end of it against the hard palate into the pharynx without inserting the fingers into the mouth of the patients. The device has a built-in bite block and it has a gastric channel and an epiglottis blocker.  
Intervention  Insertion of Ambu Aura Gain   The device insertion technique will be based on anufacturer’s recommendation. Ventilator parameters will be adjusted according to the patient in all cases. 
Intervention  Insertion of I-gel   The device insertion technique will be based on anufacturer’s recommendation. We will use “finger technique” for all the insertions. Ventilator parameters will be adjusted according to the patient in all cases. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Patients age group 3-10 years
2.Either gender
3.Weight 10-35 kg
4.ASA physical status I/II
5.Patients admitted in SSGH and posted for 6.Elective surgeries requiring general anesthesia ( abdominal surgeries, upper limb surgeries, lower limb surgeries, head and neck surgeries etc. )
 
 
ExclusionCriteria 
Details  1.Patient with risk factors of difficult airway (mouth opening of < 2cm, mallampatti class III and IV, limited neck extension, history of previous difficult tracheal intubation).
2.Patients with recent upper respiratory tract infection.
3.Patient with any known pulmonary and cardiovascular diseases.
4.Patient with any conditions that increase the risk of gastro esophageal regurgitation.
5.Parents or guardian not willing for participation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The oropharyngeal seal pressure of I-gel is higher than Ambu Aura Gain in their individual studies. Whereas insertion of Ambu aura gain is faster than I-Gel.  at 5 minute after insertion of the device, oropharyngeal leak pressure will be noted. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes are haemodynamic and respiratory parameters.   These secondary outcomes are observed throughout the duration 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)   23/05/2019 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Publication will be done after completion of the trial. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

           As newer pediatric sized supra-glottic airway devices like I-gel and Ambu Aura Gain  are  available for use in clinical practice in children.  It is important to evaluate their clinical performance and safety to establish superiority or equivalence to the existing devices. So, we choose this study to evaluate and compare overall performance of I-gel versus Ambu Aura Gain in pediatric patients undergoing general anesthesia.  To compare the clinical performance of   I gel with  Ambu Aura Gain in pediatric population for providing adequate airway seal  under controlled mechanical ventilation under general anesthesia.

 
Close