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CTRI Number  CTRI/2019/08/020691 [Registered on: 13/08/2019] Trial Registered Prospectively
Last Modified On: 17/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISION OF TWO AIRWAY DEVICES IN PATIENTS RECEIVING GENERAL ANAESTHESIA 
Scientific Title of Study   A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY OF I-GEL VERSUS BASKA MASK IN PATIENTS RECEIVING GENERAL ANAESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Bhimala Naga Ramya 
Designation  post graduate 
Affiliation  pondicerry institute of medical sciences 
Address  plot no. 9, muncipal road,besides national super market, Ganapathichettikulam,kalapet, podicherry.
pondicerry institute of medical sciences, ganapathichettikulam,kalapet pondicherry.605014
Pondicherry
PONDICHERRY
605014
India 
Phone  08374265969  
Fax    
Email  oschinramya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRMAMIE ZACHARIAH 
Designation  professor  
Affiliation  pondicherry institute od medical science 
Address  department of anesthesiology,pondicerry institute of medical sciences, ganapathichettikulam,kalapet pondicherry.

Pondicherry
PONDICHERRY
605014
India 
Phone  8344252595  
Fax    
Email  mamiezac@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Bhimala Naga Ramya 
Designation  post graduate 
Affiliation  pondicherry institute of medical science 
Address  plot no. 9, muncipal road besides national super market, Ganapathichettikulam
plot no. 9, muncipal road besides national super market, Ganapathichettikulam
Pondicherry
PONDICHERRY
605014
India 
Phone  08374265969  
Fax    
Email  oschinramya@gmail.com  
 
Source of Monetary or Material Support  
pondicherry institute of medical science 
 
Primary Sponsor  
Name  pondicherry institute of medical sciences 
Address  pondicerry institute of medical sciences, ganapathichettikulam,kalapet pondicherry.605014 
Type of Sponsor  Private medical college 
 
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 
Bhimala naga ramya  pondicherry institute of medical science  pondicherry institute of medical science, Ganapathichettikulam,kalapet,pondicherry
Pondicherry
PONDICHERRY 		 08374265969

oschinramya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PONDICHERRY INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  baska mask  comparision of igel versus baska mask 
Intervention  igel  comparision of igel wih baska mask 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients coming under American Society of Anesthesiologists grade I or II
ASA I- Normal healthy individuals
ASA II-Patient with mild systemic disease well compensated which include current smoker, mild lung disease, social drinker, well controlled Diabetes mellitus and hypertension.
2.Age : above 18 yrs. and below 65yrs
3.Mallampati grade I & II.
4.Surgeries lasting for 1 to 3 hours (like short gynaecologic procedures, hernioplasties, incision and drainage and fibroadenoma excision.)
 
 
ExclusionCriteria 
Details  1.Emergency surgeries
2.Patients with known gastrointestinal reflux, sore throat, upper respiratory airway infections.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate igel and baska mask’ oropharyngeal sealing pressure (OSP)   2021 may 
 
Secondary Outcome  
Outcome  TimePoints 
1.The ease of insertion.
2.To determine the success rate of insertion based on positioning of the igel and baska mask
3.To detect the hemodynamic responses induced by airway insertion (blood pressure, heart rate, oxygen saturation and end-tidal carbon dioxide (EtCO2)).
4.The incidence of postoperative complications such as the presence of laryngospasm on emergence, blood on the mask, sore throat.
 		 INTRA OP AND POST OP TILL FIRST 24HRS 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/08/2019 
Date of Study Completion (India) 15/04/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/04/2020 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

TITLE

          A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY OF I-GEL VERSUS BASKA MASK IN PATIENTS RECEIVING GENERAL ANAESTHESIA

SUMMARY

TYPE OF STUDY:

A Prospective randomized comparative study.

STUDY POPULATION:

Patients posted for elective surgeries under general anaesthesia lasting for 1 to 3 hours at PIMS were included in our study. 

SAMPLE SIZE:

Fifty patients were randomized into two groups of twenty five each.

PERIOD OF STUDY:

October 2018 to April 2020.

OBJECTIVES:

1.    To evaluate the oropharyngeal sealing pressure (OSP) of i-gel and baska mask.

2.    The ease of insertion (assessed by the duration of time taken to insert them successfully and the number of insertion attempts).

3.    To determine the success rate of insertion based on positioning of the i-gel and baska mask confirmed by boroscope.

4.    To detect the hemodynamic responses induced by airway insertion (blood pressure, heart rate, oxygen saturation and end-tidal carbon dioxide (EtCO2).

5.    The incidence of postoperative complications such as the presence of laryngospasm on emergence, blood on the mask, sore throat.

METHODS:

Fifty patients posted for elective surgery under General Anaesthesia lasting for 1 to 3 hours were enrolled and randomized into two groups I and B.

1.    Group I – I gel was used

2.    Group B – Baska mask was used

OUTCOME MEASURES:

1.    Oropharyngeal Sealing Pressure

2.    Number of Attempts

3.    Grade of Ease of Insertion

4.    Duration of Insertion

PARAMETERS MONITORED:

The following parameters were recorded at the time of insertion and every minute for the first 5 minutes and then, every 5mins for 15 minutes after successful insertion-

1.    Heart and Blood pressure

2.    EtCO2 and SpO2

The following parameters are noted after extubation–

1.    Laryngospasm

2.    Blood staining on the device or in mouth during suction.

3.    Sore throat at half an hour after extubation, 2nd hour, 4th hour, 6th hour and 24 hours.

RESULTS:

·       The Oropharyngeal Sealing Pressure was more with Group B (29.4 cm of H2O) than Group I (26.32 cm of H2O).

·       Number of Attempts of Insertion and Grade of Ease of Insertion in both the groups were similar and had no statistical difference.

·       Mean duration of insertion was less in Group I (13.28 s) than Group B (13.80 s), but statistically not significant.

·       Parameters like blood pressure, heart rate, SpO2 and ETCO2 were compared and no statistical difference.

·       No complications occurred in either group.

CONCLUSION

•        Oropharyngeal sealing pressure with Baska mask was better when compared with I gel (P <0.042).

•        Time taken to insert was similar in both the groups.

•        But ease of insertion and number of attempts of insertions were similar in both the groups.

•        There was no haemodynamic changes in both the groups within the study period.

•        There were no complications with either of the SAD’s.


 
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