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CTRI Number  CTRI/2016/01/006498 [Registered on: 08/01/2016] Trial Registered Retrospectively
Last Modified On: 07/01/2016
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of Air Q, I Gel and Baska mask in the anaesthetised patients  
Scientific Title of Study   Randomised comparison of the oropharyngeal leak pressure of Air Q, I Gel and Baska mask in the anaesthetised patients undergoing elective surgery 
Trial Acronym  AQIGB- Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikas Saini 
Designation  Assistant Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia PGIMER Sector 12 Chandigarh
Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  7087008119  
Fax    
Email  drvsaini@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vikas Saini 
Designation  Assistant Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia PGIMER Sector 12 Chandigarh
Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  7087008119  
Fax    
Email  drvsaini@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vikas Saini 
Designation  Assistant Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia PGIMER Sector 12 Chandigarh
PGIMER Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  7087008119  
Fax    
Email  drvsaini@gmail.com  
 
Source of Monetary or Material Support  
PGIMER,sector 12, Chandigarh 
 
Primary Sponsor  
Name  PGIMER 
Address  Sector 12 Chandigarh-160012 
Type of Sponsor  Research institution and hospital 
 
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 Vikas Saini  PGIMER  Nehru Hospital,fourth floor, A block, PGIMER, Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH 		 7087008119

drvsaini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Scheduled for surgery in supine position under general anaesthesia with a total duration of less than one hour ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I /II scheduled for surgery in supine position under general anaesthesia with a total duration of less than one hour will be included in the study. 
 
ExclusionCriteria 
Details  1. Gastro-esophageal reflux disease
2. PriorEsophagectomy
3. Hiatus hernia
4. Prior h/o of vomiting within 24hrs after surgery
5 .Known oropharyngeal morbidities
6. Full stomach with risk of aspiration
7. BMI>35kg/m2
8. Any condition which requires endotracheal intubation
9. Patientsunwilling to participate in study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the oropharyngeal leak pressure of all three airway device viz., air-Q, i-gel, Baska mask  5 minutes after insertion of airway 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the ease of insertion of device, effective airway insertion time, rates of successful insertion, ease of gastric tube insertion, airway manipulations during insertion, hemodynamic changes, intra operative and post operative device related oropharyngeal morbidities in anaesthetized non paralyzed adult patients undergoing elective surgeries.  Throughout duration of surgery 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   05/11/2015 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

PRIMARY AIM: To compare the oropharyngeal leak pressure of all three airway device viz., air-Q, i-gel, Baska mask

 SECONDARY AIMS: To compare the ease of insertion of device, effective airway insertion time, rates of successful insertion, ease of gastric tube insertion, airway manipulations during insertion, hemodynamic changes, intra operative and post operative device related oropharyngeal morbidities in anaesthetized non paralyzed adult patients undergoing elective surgeries.

HYPOTHESIS: Baska would have higher oropharyngeal leak pressure compared to air Q and i-gel.

To determine the leak pressure, the expiratory valve will be closed with a fresh gas flow of 3 L/min until equilibrium will be reached and then released completely (not allowed to exceed 40 cm H2O). Presence or absence of gastric insufflations by epigastric auscultation will be performed during leak pressure testing.Gas leakage will be determined at the (1) mouth (audible), (2) the stomach (epigastric auscultation) or (3)the drainage tube (bubbling of lubricant placed on the proximal end of the drainage tube).

 
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