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CTRI Number  CTRI/2018/06/014473 [Registered on: 08/06/2018] Trial Registered Prospectively
Last Modified On: 07/06/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative efficacy and safety of two supraglottic airway devices during general anaesthesia in children 
Scientific Title of Study   Comparative efficacy and safety of I-gel supraglottic airway and self pressurizing Air-Q intubating laryngeal airway during general anaesthesia in infants: A prospective randomised 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 Ravinder Kumar Pandey 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences New Delhi 
Address  Room No 5016 teaching block Department of Anaesthesiology AIIMS
Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS
New Delhi
DELHI
110029
India 
Phone  9868397817  
Fax    
Email  ravindrapandey1972@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha Pangasa 
Designation  Senior Resident 
Affiliation  All India Institute Of Mediical Sciences New Delhi 
Address  Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS
Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS
New Delhi
DELHI
110029
India 
Phone  9810383313  
Fax    
Email  nehapangasa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neha Pangasa 
Designation  Senior Resident 
Affiliation  All India Institute Of Mediical Sciences New Delhi 
Address  Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS
Department of Anaesthesiology Pain Medicine & Critical Care 5th floor teaching block AIIMS
New Delhi
DELHI
110091
India 
Phone  9810383313  
Fax    
Email  nehapangasa@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Pain Medicine and Critical care AIIMS New Dehi 
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain medicine and Critical care 
Address  All India Institute Of Medical Sciences New Delhi 
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 Ravinder Kumar Pandey  All India Institute Of Medical Sciences  Main Operation theater , 5th floor. Rajendra Prasad Centre for ophthalmic sciences
New Delhi
DELHI 
9868397817

ravindrapandey1972@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee of All India Institute Of Medical Sciences New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA I and II children below 1 year of age posted for ophthalmic surgery of 20 min-2 hr duration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Air-Qsp  The air-Qsp, which is a new self-pressurizing masked laryngeal airway has a unique cuff design. The mask cuff of Air-Qsp inflates appropriately upon inhalation with positive pressure ventilation, and decompresses upon exhalation to the level of PEEP. Moreover, the cuff is not overinflated by high positive pressure or nitrous oxide, because it is not a closed cavity. Six colour-coded single patient use sizes Air-Qsp are available (1.0, 1.5, 2.0, 2.5, 3.5, 4.5).Acceptable clinical performance has been demonstrated with the Air-Qsp for a variety of procedures in infants and children with spontaneous and positive pressure ventilation. 
Comparator Agent  I-gel  The i-gel airway (Intersurgical Ltd, Wokingham,Berkshire, UK) is a novel supraglottic device made up of a thermoplastic elastomer (SEBS, styrene ethylene butadiene styrene) with a soft durometer (hardness) and gel-like feel. The mask of the i-gel is designed anatomically to fit the perilaryngeal and hypopharyngeal structures without the use of an inflatable cuff. Paediatric i-gel is available in different sizes (1, 1.5, 2, and 2.5) according to the weight of the children.In children the i-gel is very easy to insert and no learning curve is needed before a high success insertion rate is obtained. A positive pressure is easily achieved without gastric inflation or pharyngeal leak. Moreover, the drainage tube makes it possible to confirm the correct position of the device and allows gastric drainage. Therefore, the i-gel appears to be safe for paediatric airway management.  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  Infants below 1yr. of age
Posted for Only elective ophthalmic surgery
ASA I & II patients
Duration of surgery (20 mins-2 hrs)  
 
ExclusionCriteria 
Details  All patients above 1 year of age
Not willing to consent (Consent taken from parents)
Infants with any-airway anomalies, active URTI, known difficult airway, lung disease requiring high PEEP
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oropharyngeal Leak Pressure (in cm H2O)   Oropharyngeal leak pressure will be measured at 3 times: after insertion and fixation of the device, 10 min after insertion and at the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. First insertion success rate
2. Time to insert (in seconds)
3. No. of attempts for successful insertion
4. Fibreoptic bronchoscopic view of glottis through the supraglottic airway device
5. Post op. Complications (repeated episodes of cough, laryngospasm, desaturation)

 
Time to Insert- Time between picking up the device and chest rise with PPV
Fibre-optic bronchoscopic (FOB) view-breathing system will be briefly disconnected after insertion and confirmation of device
and a 3-mm fiberscope will be inserted through the airway port to evaluate glottic view.
Post-operative Complications- Blood stain on device (oropharyngeal trauma), repeated episodes of cough, laryngospasm, bronchospasm or desaturation will be noted after removal of device at the end of surgery
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/06/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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)?  

Brief Summary  

We will be comparing the efficacy and safety of i-gel supraglottic airway and self pressurizing air-q intubating laryngeal airway during general anaesthesia in infants. The study will include 100 infants, ASA I and II, posted for elective ophthalmic surgery of 20 min-2 hrs duration. All patients above 1 year of age, not willing to consent and infants with any airway anomalies, active URTI, known difficult airway or lung disease requiring high PEEP will be excluded from the study. Randomization will be done by computer generated random number tables and group allocation will be done by opening sealed opaque envelopes. The primary objective of our study is to compare the oropharyngeal leak pressure of i-gel and air-Qsp and the secondary objectives are to compare the two devices in terms of- number of attempts to successfully insert the device, time to insert, fibre-optic view of glottis through the device and post-operative complications like cough, laryngospasm and desaturation.

 

All ASA I-II infants will receive standardised general anaesthesia. A pre-anaesthetic check-up will be done for all patients one day prior to the surgery. On being shifted to operation theatre, the standard monitors will be attached. Anaesthesia will be induced by using sevoflurane in oxygen by increasing inspired concentration of sevoflurane (from 2-8%) till the loss of eyelash reflex. 22 or 24G IV cannula will be secured. Then intravenous fentanyl 1μg/kg and atracurium 0.25 mg/kg will be given. After 3 minutes of intermittent positive pressure ventilation, appropriate size (depending on body weight) of supraglottic device (according to the group allocated) lubricated with jelly will be inserted and circuit attached. Chest rise and ventilation will be confirmed. Satisfactory SGA placement will be confirmed by the appearance of square wave capnogram and absence of leak around SGA. A maximum of 3 attempts will be allowed. If more than 3 attempts are required, then it will be considered as failure and an alternative device or endotracheal intubation will be done Oropharyngeal leak pressure will be measured at 3 times: after insertion and fixation of the device, 10 min after insertion and at the end of surgery. After initial measurement of oropharyngeal leak pressure, the breathing system will be briefly disconnected and a 3-mm fiberscope will be inserted through the airway port to evaluate glottic view. Anaesthesia will be maintained with isoflurane 1- 2% (MAC 0.8 – 1.0) in O2: Air mixture with Fio2 of 0.5. Pressure controlled ventilation to be used to maintain normocarbia (35 – 40 cm of H2O).. Intra-operative analgesia will be maintained by IV Paracetamol (7.5 mg/kg). At the end of surgery, isoflurane will be turned off & 100% O2 will be administered. Muscle relaxation will be reversed by intravenous neostigmine (50μg/kg) & glycopyrrolate (10μg/kg). Adequate tidal volume & regular respiration will be maintained. Oropharyngeal suctioning will be done & device will be removed. Presence of any blood stain or any tongue, lip or dental trauma will be noted. Any post-operative complication such as repeated episodes of cough, laryngospasm, bronchospasm or desaturation will be noted till 1 hr post operatively.

 


 
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