Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®.
NCT ID: NCT03140228
Last Updated: 2019-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2017-06-15
2017-09-01
Brief Summary
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Many factors can contribute to postoperative sore throat and the incidence has been found to vary with the method by which airway is managed.
The study is conducted to compare the severity and frequency of postoperative sore throat in children undergoing elective surgery following the use of AmbuAuraOnce LMA and I-Gel. The study will be done in children who are able to self-report the severity of sore throat.
This study will help us to determine which supraglottic device (I-gel vs. AmbuAuraOnce LMA) is better in terms of causing less complication spells of sore throat. The use of such device will not only reduce the severity and frequency of postoperative sore throat that may affect the activities of patient after leaving hospital but also will improve satisfaction level of patient and parents.
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Detailed Description
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The objective of our study is to assess the frequency and severity of postoperative sore throat by comparison between two supraglottic devices, AuraOnce Laryngeal Mask Airway (LMA) and I-gel in children undergoing elective lower abdominal or orthopedic surgery.
HYPOTHESIS: Use of I-gel in children undergoing elective lower abdominal or orthopedic surgery is associated with decrease frequency and severity of postoperative sore throat as compared to use of AuraOnce Laryngeal Mask Airway.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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I-Gel group
I-gel will be used for maintenance of airway during general anaesthesia
I-Gel
I-gel is the single use supraglottic airway from intersurgical, UK (Intersurgical Ltd, Wokingham, Berkshire, UK) with an anatomically designed mask made of a gel like thermoplastic elastomer to fit over perilaryngeal and hypopharyngeal structures. It is designed to separate the gastrointestinal and respiratory tracts and also allow a gastric tube to be passed into the stomach.
LMA ambu auraonce group
LMA ambu auraonce will be used for maintenance of airway during general anaesthesia
LMA
The AmbuAuraOnce (Ambu A/S, Ballerup, Denmark) is a supraglottic airway device with an inflatable cuff. It is a disposable device as well, but unlike I-gel, it does not feature a gastric channel.
Interventions
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I-Gel
I-gel is the single use supraglottic airway from intersurgical, UK (Intersurgical Ltd, Wokingham, Berkshire, UK) with an anatomically designed mask made of a gel like thermoplastic elastomer to fit over perilaryngeal and hypopharyngeal structures. It is designed to separate the gastrointestinal and respiratory tracts and also allow a gastric tube to be passed into the stomach.
LMA
The AmbuAuraOnce (Ambu A/S, Ballerup, Denmark) is a supraglottic airway device with an inflatable cuff. It is a disposable device as well, but unlike I-gel, it does not feature a gastric channel.
Eligibility Criteria
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Inclusion Criteria
* ASA (American Society of Anesthesiologists) I and ASA II patients
* Scheduled for elective lower abdominal surgery (inguinal hernia repair or circumcision) or orthopedic surgery (upper and lower limb) under General anesthesia.
Exclusion Criteria
* Difficult airway(difficult mask ventilation or difficult laryngoscopy, Cormack-Lehane grade more than 2 in patient history, trismus, limited mouth opening, trauma or mass)
* Children who are unable to self-report pain using a four-point categorical pain scale
* Refusal of the parent
* Refusal of the child to give assent
* Patients having pre-existing sore throat or symptoms of Upper respiratory tract infection.
* Obese children i.e. BMI for age percentile equal to or greater than the 95th percentile on BMI-for-age percentile growth charts.
6 Years
16 Years
ALL
Yes
Sponsors
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Aga Khan University
OTHER
Responsible Party
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Dr. Malika Hameed
Resident Anaesthesiology
Principal Investigators
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Malika H Dhanani, FCPS
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University
Locations
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Aga Khan University
Karachi, Sindh, Pakistan
Countries
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References
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Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
Mokhtar AM, Choy CY. Postoperative sore throat in children: comparison between proseal LMA and classic LMA. Middle East J Anaesthesiol. 2013 Feb;22(1):65-70.
Kim H, Lee JY, Lee SY, Park SY, Lee SC, Chung CJ. A comparison of i-gel and LMA Supreme in anesthetized and paralyzed children. Korean J Anesthesiol. 2014 Nov;67(5):317-22. doi: 10.4097/kjae.2014.67.5.317. Epub 2014 Nov 26.
Theiler LG, Kleine-Brueggeney M, Luepold B, Stucki F, Seiler S, Urwyler N, Greif R. Performance of the pediatric-sized i-gel compared with the Ambu AuraOnce laryngeal mask in anesthetized and ventilated children. Anesthesiology. 2011 Jul;115(1):102-10. doi: 10.1097/ALN.0b013e318219d619.
Beylacq L, Bordes M, Semjen F, Cros AM. The I-gel, a single-use supraglottic airway device with a non-inflatable cuff and an esophageal vent: an observational study in children. Acta Anaesthesiol Scand. 2009 Mar;53(3):376-9. doi: 10.1111/j.1399-6576.2008.01869.x.
Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and nonconventional usage. Anesth Analg. 1996 Jan;82(1):129-33. doi: 10.1097/00000539-199601000-00023.
McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia. 1999 May;54(5):444-53. doi: 10.1046/j.1365-2044.1999.00780.x.
Other Identifiers
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4249-Ane-ERC-16
Identifier Type: -
Identifier Source: org_study_id
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