COMPARISON of 2 ANAESTHESIA DEVICES IN CHILDREN UNDERGOING CATARACT SURGERY
- Conditions
- Otherwise healthy patients undergoing Cataract Surgery
- Registration Number
- CTRI/2014/06/004682
- Lead Sponsor
- PGIMER Chandigarh
- 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 undergoinggynaecological laparoscopic surgery with controlled ventilation. Anaesthesia2010; 65: 1173–79
2. GatwardJJ, Cook TM, Seller C et al. Evaluation of the size 4 i-gel airway in one hundred non-paralysedpatients. 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](http://www.ncbi.nlm.nih.gov/pubmed?term=Jagannathan%20N%5BAuthor%5D&cauthor=true&cauthor_uid=23189931), [Sommers K](http://www.ncbi.nlm.nih.gov/pubmed?term=Sommers%20K%5BAuthor%5D&cauthor=true&cauthor_uid=23189931), [Sohn LE](http://www.ncbi.nlm.nih.gov/pubmed?term=Sohn%20LE%5BAuthor%5D&cauthor=true&cauthor_uid=23189931) et al. A randomizedequivalence trial comparing the i-gel and laryngealmask airway Supreme in children.[PaediatrAnaesth.](http://www.ncbi.nlm.nih.gov/pubmed/23189931 "Paediatric anaesthesia.") 2013 ; 23: 127-33.
5. JagannathanN, Sohn LE, Chang E et al. A cohort evaluation of the laryngeal mask airway-Supreme™ in children. PediatricAnesth 2012; 22: 759–64.
6. JagannathanN, Sohn LE, Sawardekar A et al. A randomised comparison of the LMA SupremeTMand LMA ProSealTM in children. Anaesthesia 2012; 67: 632–39.
7. JagannathanN, Sohn LE, Sawardekar A et al. A randomised trial comparing the laryngeal maskairway Supreme™ with the laryngeal mask airway Unique™ in children. Anaesthesia2012; 67: 139–44.
8. HughesC, Place K, Berg S et al. A clinical evaluation of the i-gel(TM)supraglotticairway device in children. PediatrAnesth 2012; 22: 765–71.
9. TheilerLG, Kleine-Brueggeney M, Luepold B et al. Performance of the pediatric-sizedi-gel compared with the AmbuAuraOnce laryngeal mask in anesthetized andventilated children. Anesthesiology 2011; 115: 102–10.
10. LeeJR, 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. BeringerRM, Kelly F, Cook TM et al. A cohort evaluation of the paediatric i-gel airwayduring anaesthesia in 120 children. Anaesthesia 2011; 66: 1121–112.
12. [DumanA](http://www.ncbi.nlm.nih.gov/pubmed?term=Duman%20A%5BAuthor%5D&cauthor=true&cauthor_uid=11442858), [OgünCO](http://www.ncbi.nlm.nih.gov/pubmed?term=Og%C3%BCn%20CO%5BAuthor%5D&cauthor=true&cauthor_uid=11442858), [OkesliS](http://www.ncbi.nlm.nih.gov/pubmed?term=Okesli%20S%5BAuthor%5D&cauthor=true&cauthor_uid=11442858). The effect on intraocular pressure oftracheal intubation or laryngeal mask insertion during sevoflurane anaesthesiain children without the use of muscle relaxants. [PaediatrAnaesth.](http://www.ncbi.nlm.nih.gov/pubmed/11442858 "Paediatric anaesthesia.") 2001;11:421-4.
13. [IsmailSA](http://www.ncbi.nlm.nih.gov/pubmed?term=Ismail%20SA%5BAuthor%5D&cauthor=true&cauthor_uid=21455075), [BisherNA](http://www.ncbi.nlm.nih.gov/pubmed?term=Bisher%20NA%5BAuthor%5D&cauthor=true&cauthor_uid=21455075), [KandilHW](http://www.ncbi.nlm.nih.gov/pubmed?term=Kandil%20HW%5BAuthor%5D&cauthor=true&cauthor_uid=21455075) et al. Intraocular pressure and haemodynamicresponses to insertion of the i-gel, laryngeal mask airway or endotrachealtube. [Eur J Anaesthesiol.](http://www.ncbi.nlm.nih.gov/pubmed/21455075 "European journal of anaesthesiology.") 2011;28:443-8.
14. [SahinA](http://www.ncbi.nlm.nih.gov/pubmed?term=Sahin%20A%5BAuthor%5D&cauthor=true&cauthor_uid=22494062), [TüfekA](http://www.ncbi.nlm.nih.gov/pubmed?term=T%C3%BCfek%20A%5BAuthor%5D&cauthor=true&cauthor_uid=22494062), [CingüAK](http://www.ncbi.nlm.nih.gov/pubmed?term=Cing%C3%BC%20AK%5BAuthor%5D&cauthor=true&cauthor_uid=22494062) et al. The effect of I-gel ™ airway onintraocular pressure in pediatric patients who received sevoflurane ordesflurane during strabismus surgery. [PaediatrAnaesth.](http://www.ncbi.nlm.nih.gov/pubmed/?term=The+effect+of+I-gelTM+airway+on+intraocular+pressure+in "Paediatric anaesthesia.") 2012 ; 22 :772-5.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 47
ASA I and II Patients.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
PGIMER, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
PGIMER, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDr Sameer SethiPrincipal investigator9317851002sethi.sameer@rediffmail.com