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CTRI Number  CTRI/2024/08/072204 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison between the working performance of two supraglottic airway devices I-gel and Air-Q among patients posted for surgery under general anesthesia.  
Scientific Title of Study   To evaluate the working performance of two supraglottic airway devices - I-gel and Air-Q among patients posted for elective surgeries undergoing general anesthesia in general surgery and gynecology operation theater  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Kugashiya 
Designation  1st year resident  
Affiliation  Government Medical College Bhavnagar 
Address  Department of Anesthesiology, government Medical college and hospital Bhavnagar
SIR T Hospital kalanala road bhavnagar 364001
Bhavnagar
GUJARAT
364001
India 
Phone  9924127318  
Fax    
Email  kugashiyapriyanka07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Chandrika Bhut 
Designation  Assistant Professor, M.D. Anesthesiology 
Affiliation  Government Medical College Bhavnagar 
Address  Department of Anesthesiology, government Medical college and hospital Bhavnagar-364001
Sir T hospital kalanala road bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9427040221  
Fax    
Email  dr.chandrika62@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Chandrika Bhut 
Designation  Assistant Professor, M.D. Anesthesiology 
Affiliation  Sir Takhtasinhji general hospital bhavnagaqr 
Address  Department of Anesthesiology, government Medical college and hospital Bhavnagar-364001
Sir T hospital kalanala road bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  9427040221  
Fax    
Email  dr.chandrika62@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Sir T Hospital , Kalanala road, BHavnagar 364001 
 
Primary Sponsor  
Name  Government medical College Bhavnagar 
Address  Department of Anaesthesiology, Sir Takhtasinhji government medical college and hospital Bhavnagar 
Type of Sponsor  Government 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 
Dr Priyanka Kugashiya  Sir T hospital Bhavnagar  Department of anesthesiology, Sir Takhtasinhji hospital Bhavnagar 364001
Bhavnagar
GUJARAT 		 9924127318

kugashiyapriyanka07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Govt Medical College, Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Air Q  supraglottic airway device - Air Q will be used among the patients posted for elective surgeries (Maximum duration 2 hours)under General Anesthesia for securing the airway and hemodynamic parameters will be observed and compare with I-Gel 
Comparator Agent  I-Gel  supraglottic airway device - I-Gel will be used among the patients posted for elective surgeries (Maximum duration 2 hours)under General Anesthesia for securing the airway and hemodynamic parameters will be observed and compare with AirQ 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients age 18 to 60 years
2) ASA (American society of anesthesiologist’s) grade I , II, III
3) Scheduled for elective surgery under general anesthesia
4) BMI less than 30kg/m2
 
 
ExclusionCriteria 
Details  1) Patients with difficult airway and Mallampati Grade III and IV
2) Patients with history of supraglottic growth
3) Duration of surgery longer than 2 hours
4) Patients with known case of respiratory illness (like COPD , asthma, bronchitis etc.)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess following parameters in both the groups
1) working performance in terms of oropharyngeal leak pressure, EtCO2 and Mean tidal expiration volume
2) insertion characteristics in terms of insertion time , number of attempts, manipulations required during insertion and failed insertion ,if any.
 		 Before Insertion, After insertion , After 1 minutes,5minutes ,10 minutes and after removal  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the following parameters in both the groups
1) Ease of insertion of orogastric tube through SGA devices.
2) Perioperative hemodynamic response of the patient in terms of pulse rate and mean atrial pressure.
3) Side effects and Complications if any (blood stained device, sore throat and laryngo-bronchospasm)
 		 15 months 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   01/09/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   “Evaluation of the working performance of two supraglottic airway devices - I-gel and air-Q among the patients posted for elective surgeries under General Anesthesia: Single blind Randomized control study”

Interventions: Air-Q will be compared to I-gel for securing the airway.
Aim : To evaluate the working performance of two supraglottic airway devices - I-gel and Air-Q  among patients posted for elective surgeries undergoing general anesthesia.
WHY THIS STUDY IS ESSENTIAL
 Laryngoscopy and endotracheal intubation produce reflex sympathetic stimulation and causes tachycardia, hypertension,  and hemodynamic instability. (2)
Supraglottic airway devices(SGA) does not require Laryngoscopy and thus, it improves hemodynamic stability, no airway manipulation related complication, reduced intra operative anesthesia requirement and has less post operative complications compared to conventional intubation technique. (1,2)
This study will provide information about which supraglottic airway device - I-gel and Air-Q which is better in terms of insertion success and working performance. It will generate evidence about which one to prefer. Since both the devices can be used in same set of patients, it will guide to know which one between the two is good for the patient.
Objectives

Primary Objectives: to assess following parameters in both the groups

         1) working performance in terms of oropharyngeal leak pressure, EtCO2 and Mean tidal expiration volume

         2) insertion characteristics in terms of insertion time , number of attempts, manipulations required during insertion and

                     failed insertion ,if any.

Secondary Objectives: To assess the following parameters in both the groups 

        1) Ease of insertion of orogastric tube through SGA devices.

        2) Perioperative hemodynamic response of the patient in terms of  pulse rate and mean atrial pressure.

        3) Side effects and Complications if any (blood stained device, sore throat and laryngo-bronchospasm)

• Study design: Single blind Randomized control study
•Study population: Patients of either gender undergoing elective surgeries under general anesthesia
•Study setting: General surgery and Gynecology operation theater, Govt. Medical College , Bhavnagar
•Study Duration: 15months
•Time period for data collection: 12months
•Sample size: 88 (44 in each group)

•Sampling method – Simple random sampling
Inclusion criteria

                1) Patients age 18 to 60 years

                2) ASA (American society of anesthesiologist’s) grade I , II, III

                3) Scheduled for elective surgery under general anesthesia

                4) BMI<30kg/m2

Exclusion criteria

                1) Patients with difficult airway and Mallampati Grade III and IV

                2) Patients with history of supraglottic growth

                3) Duration of surgery longer than 2 hours

                4) Patients with known case of  respiratory illness (like COPD , asthma, bronchitis etc.
LIST OF VARIABLES
•Independent variables: Age, Gender, Comorbidities, Type of SGA
•Dependent variables: Ease of insertion, timing of insertion, Oropharyngeal leak pressure, ease of inserting orogastric tube
•Confounding factors: Overweight (BMI 25-30kg/m2) , neck mobility, neck circumference, thyro-mental distance
METHODOLOGY

After approval from ethics committee and CTRI registration, All the patients who will be eligible in inclusion criteria will be included in this study.

Preanesthetic checkup of the patient and written informed consent of the patient will be taken in local language.

 Patients will be randomized using computer generated random number sequence method into either group A or group I. Airway will be secured with Air-q and I-gel in group A and I respectively.


 
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