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Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®.

Primary Purpose

Laryngeal Masks, Pharyngitis, Minors

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
I-Gel
LMA
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laryngeal Masks

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 6 to 16 year old patients of both gender
  • 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:

  • Patients with risk of aspiration (incomplete NPO (Nil per oral), Gastroesophageal reflux disease, Congenital anatomic abnormalities of aero digestive tract, delayed gastric emptying, altered mental status)
  • 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.

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I-Gel group

LMA ambu auraonce group

Arm Description

I-gel will be used for maintenance of airway during general anaesthesia

LMA ambu auraonce will be used for maintenance of airway during general anaesthesia

Outcomes

Primary Outcome Measures

Frequency and severity of postoperative sore throat
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. Postoperative Sore Throat: Constant pain or discomfort in the throat which is independent of swallowing postoperatively for 24 hours. Severity of Sore throat: The severity of sore throat will be measured by a four-point categorical pain scale. Grading of severity is as follow: 0 = no sore throat mild (complains of sore throat only on asking) moderate (complains of sore throat on his/her own) severe (change of voice or hoarseness, associated with throat pain). Chi-square test will be applied to compare frequency and severity of post-operative sore throat between two groups. P ≤ 0.05 will be considered as significant.

Secondary Outcome Measures

Immediate complications
Frequency will be calculated for immediate complications which includes laryngospasm, stridor, coughing, aspiration etc.
Insertion time
time of insertion of supraglottic device
Ease of insertion
Ease of insertion
Total number of attempts
maximum three attempts
Oropharyngeal seal pressure
seal pressure

Full Information

First Posted
April 29, 2017
Last Updated
August 1, 2019
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT03140228
Brief Title
Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®.
Official Title
Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel® in Children Undergoing Elective Lower Abdominal or Orthopedic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Sore throat is minor but well recognized complaint after receiving general anaesthesia. It is rated as 8th most undesirable outcome in postoperative period.It not only affects the patient's satisfaction but also can affect patient activities after leaving hospital. 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.
Detailed Description
OBJECTIVE: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Masks, Pharyngitis, Minors, Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I-Gel group
Arm Type
Experimental
Arm Description
I-gel will be used for maintenance of airway during general anaesthesia
Arm Title
LMA ambu auraonce group
Arm Type
Active Comparator
Arm Description
LMA ambu auraonce will be used for maintenance of airway during general anaesthesia
Intervention Type
Device
Intervention Name(s)
I-Gel
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
LMA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency and severity of postoperative sore throat
Description
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. Postoperative Sore Throat: Constant pain or discomfort in the throat which is independent of swallowing postoperatively for 24 hours. Severity of Sore throat: The severity of sore throat will be measured by a four-point categorical pain scale. Grading of severity is as follow: 0 = no sore throat mild (complains of sore throat only on asking) moderate (complains of sore throat on his/her own) severe (change of voice or hoarseness, associated with throat pain). Chi-square test will be applied to compare frequency and severity of post-operative sore throat between two groups. P ≤ 0.05 will be considered as significant.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Immediate complications
Description
Frequency will be calculated for immediate complications which includes laryngospasm, stridor, coughing, aspiration etc.
Time Frame
Immediately after removal of supraglottic device
Title
Insertion time
Description
time of insertion of supraglottic device
Time Frame
5 minutes
Title
Ease of insertion
Description
Ease of insertion
Time Frame
5 minutes
Title
Total number of attempts
Description
maximum three attempts
Time Frame
5 minutes
Title
Oropharyngeal seal pressure
Description
seal pressure
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 6 to 16 year old patients of both gender 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: Patients with risk of aspiration (incomplete NPO (Nil per oral), Gastroesophageal reflux disease, Congenital anatomic abnormalities of aero digestive tract, delayed gastric emptying, altered mental status) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malika H Dhanani, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
12066737
Citation
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.
Results Reference
background
PubMed Identifier
23833853
Citation
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.
Results Reference
background
PubMed Identifier
25473460
Citation
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.
Results Reference
background
PubMed Identifier
21572318
Citation
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.
Results Reference
background
PubMed Identifier
19243322
Citation
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.
Results Reference
background
PubMed Identifier
8712387
Citation
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.
Results Reference
background
PubMed Identifier
10995141
Citation
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.
Results Reference
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Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®.

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