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CTRI Number  CTRI/2014/06/004682 [Registered on: 18/06/2014] Trial Registered Retrospectively
Last Modified On: 27/12/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   COMPARISON of 2 ANAESTHESIA DEVICES IN CHILDREN UNDERGOING CATARACT SURGERY  
Scientific Title of Study   COMPARISON OF SIZE 2 I-GELâ„¢ AIRWAY WITH SIZE 2 LARNYNGEAL MASK AIRWAY SUPREMEâ„¢ IN ANAESTHETISED NON PARALYSED CHILDREN UNDERGOING ELECTIVE CATARACT SURGERY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sameer Sethi 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research(PGIMER) 
Address  Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9317851002  
Fax    
Email  sethi.sameer@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Sahoo 
Designation  Student 
Affiliation  Post Graduate Institute of Medical Education and Research(PGIMER) 
Address  Department of Anaesthesia, Nehru Hospital, PGIMER,Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9317851002  
Fax    
Email  drasishkumarsahoo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sameer Sethi 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research(PGIMER) 
Address  Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9317851002  
Fax    
Email  sethi.sameer@rediffmail.com  
 
Source of Monetary or Material Support  
PGIMER 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  Sector 12, Chandigarh 
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 Sameer Sethi  PGIMER, Chandigarh  Department of Anaesthesia, PGIMER,Sector 12,Chandigarh
Chandigarh
CHANDIGARH 
9317851002

sethi.sameer@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Otherwise healthy patients undergoing Cataract Surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Two airway devices I-Gel and LMA Supreme  Comparison of two airway devices I-Gel and LMA Supreme in children undergoing cataract surgery  
 
Inclusion Criteria  
Age From  1.50 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  ASA I and II Patients 
 
ExclusionCriteria 
Details  1. Upper respiratory tract infection (cough, fever, rhinorrhea) at the day of surgery.
2. Respiratory tract pathology ( oropharynx, larynx )
3. Anticipated difficult airway
4. Children at increased risk of aspiration - Gastro esophageal reflux disease, non fasting status
5. Hiatus hernia
6. Lung diseases
7. Cardiorespiratory or cerebrovascular disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the oropharyngeal leak pressure of I gel with lma supreme  At 2 and 5 min and 30 min after insertion of device 
 
Secondary Outcome  
Outcome  TimePoints 
compare the ease of insertion success of insertion, intraocular pressure changes with insertion, with both the devices in anaesthesied non paralysed children undergoing elective cataract surgery.  Various time intervals after insertion of device and after 5,10,15,20,30 min 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/01/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

An oropharyngeal leak pressure or leak test is commonly performed with the laryngeal mask airway to quantify the efficacy of the seal with the airway. This value is important since it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supra cuff soiling.

In adults, the I-GEL has been shown to have similar leak pressures and efficacy when compared with the Supreme1-3 In children there is only one comparision study between two devices published recently by Jagannathan N et al in the year 2013 which demonstrated higher leak pressures for i-gel airway as compared lma supreme4. On comparing the other  studies involving lma supreme5-7  and I gel8-10 in children done separately we found that in some studies lma supreme has higher leak pressures while in some studies it was found to be equal.

Various studies have shown that insertion of supraglottic device does not cause significant  change in intraocular pressure from baseline value as compared to endotracheal tube which is associated with significant changes11  Studies have found that i- gel does not cause any change in intraocular pressure from baseline value12. Infact one study shows that I-gel insertion is associated with significantly decreased intra ocular pressure,which make it more suitable for children undergoing elective eye surgery13. Similar study involving LMA SUPREME is lacking.

 

However there is no study comparing the effectiveness, intraocular pressure changes and hemodynamic changes for both the devices in children undergoing elective eye surgery.

 

Primary aim of this study is to compare the oropharyngeal leak pressure of both the devices. We will also compare the ease and time for successful insertion, ease of gastric tube placement, intraocular pressure changes with insertion, pharyngolaryngeal morbidity and hemodynamic changes with both the devices in anaesthesied non paralysed children undergoing elective eye surgery.

 

Taking into account the most recent study we hypothesized that the I-gel would have higher oropharyngeal leak pressures to the LMA SUPREME in pediatric patients undergoing elective cataract surgery.

So due to limited number of studies and due to variation in various studies we planned to compare both the devices in children.

As we are comparing both the devices in children in terms of their effectiveness in providing ventilation we thought of comparing intraocular pressure changes and hemodynamic changes with insertion of both the devices.

References


1.      Teoh WH, Lee KM, Suhitharan T et al. Comparison of the LMA Supreme vs the i-gel in paralysed patients undergoing gynaecological laparoscopic surgery with controlled ventilation. Anaesthesia 2010; 65: 1173–79

2.      Gatward JJ, Cook TM, Seller C et al. Evaluation of the size 4  i-gel airway in one hundred non-paralysed patients. Anaesthesia. 2008; 63: 1124-30.

3.      Cook TM, Gatward JJ, Handel J et al. Evaluation of the LMA Supreme in 100 non-paralysed patients. Anaesthesia 2009; 64: 555–562.

4.      Jagannathan N, Sommers K, Sohn LE et al. A randomized equivalence trial comparing the i-gel and laryngeal mask airway Supreme in children.PaediatrAnaesth. 2013 ; 23: 127-33.

5.      Jagannathan N, Sohn LE, Chang E et al. A cohort evaluation of the laryngeal mask                                  airway-Supremeâ„¢ in children. PediatricAnesth 2012; 22: 759–64.

6.      Jagannathan N, Sohn LE, Sawardekar A et al. A randomised comparison of the LMA SupremeTM and LMA ProSealTM in children. Anaesthesia 2012; 67: 632–39.

7.      Jagannathan N, Sohn LE, Sawardekar A et al. A randomised trial comparing the laryngeal mask airway Supremeâ„¢ with the laryngeal mask airway Uniqueâ„¢ in children. Anaesthesia 2012; 67: 139–44.

8.      Hughes C, Place K, Berg S et al. A clinical evaluation of the i-gel(TM)supraglottic airway device in children. PediatrAnesth 2012; 22: 765–71.

9.      Theiler LG, Kleine-Brueggeney M, Luepold B et al. Performance of the pediatric-sized i-gel compared with the AmbuAuraOnce laryngeal mask in anesthetized and ventilated children. Anesthesiology 2011; 115: 102–10.

10.  Lee JR, Kim MS, Kim JT et al. A randomized trial comparing the i-gel (TM) with the LMA Classic (TM) in children. Anaesthesia 2012; 67: 606–11.

11.  Beringer RM, Kelly F, Cook TM et al. A cohort evaluation of the paediatric i-gel airway during anaesthesia in 120 children. Anaesthesia 2011; 66: 1121–112.

12.  Duman A, Ogün CO, Okesli S. The effect on intraocular pressure of tracheal intubation or laryngeal mask insertion during sevoflurane anaesthesia in children without the use of muscle relaxants. PaediatrAnaesth. 2001;11:421-4.

13.  Ismail SA, Bisher NA, Kandil HW et al. Intraocular pressure and haemodynamic responses to insertion of the i-gel, laryngeal mask airway or endotracheal tube. Eur J Anaesthesiol. 2011;28:443-8.

14.  Sahin A, Tüfek A, Cingü AK et al. The effect of I-gel â„¢ airway on intraocular pressure in pediatric patients who received sevoflurane or desflurane during strabismus surgery. PaediatrAnaesth. 2012 ; 22 :772-5.

 
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