Laryngeal MasksNCT03140228
Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®.
A study testing I-Gel and LMA in people with Laryngeal Masks and Pharyngitis, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Masks, Pharyngitis, Minors
- What is being tested?
- I-Gel and LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2017to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Laryngeal Masks, Pharyngitis, Minors, Anesthesia
- Being tested
- I-Gel, LMA
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-GelDevice
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.
LMADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| I-Gel group | Experimental | I-gel will be used for maintenance of airway during general anaesthesia Receives: Device: I-Gel |
| LMA ambu auraonce group | Active comparator | LMA ambu auraonce will be used for maintenance of airway during general anaesthesia Receives: Device: LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (5)
Immediate complications
Frequency will be calculated for immediate complications which includes laryngospasm, stridor, coughing, aspiration etc.
Measured: Immediately after removal of supraglottic device
Insertion time
time of insertion of supraglottic device
Measured: 5 minutes
Ease of insertion
Ease of insertion
Measured: 5 minutes
Total number of attempts
maximum three attempts
Measured: 5 minutes
Oropharyngeal seal pressure
seal pressure
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start15 Jun 2017
- Primary completion15 Aug 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Laryngeal MasksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Malika Hameed, Aga Khan University
- Investigators
- Malika H Dhanani, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140228
- Sponsor's protocol ID
- 4249-Ane-ERC-16
- Status last verified
- Aug 2019
- First submitted
- 29 Apr 2017
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12066737Mokhtar 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.
PubMed 23833853Kim 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.
PubMed 25473460Theiler 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.
PubMed 21572318Beylacq 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.
PubMed 19243322Verghese 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.
PubMed 8712387McHardy 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.
PubMed 10995141
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03140228
- Acronym / sponsor ID
- 4249-Ane-ERC-16
- Conditions
- Laryngeal Masks, Pharyngitis, Minors, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-Gel group | Experimental | Device: I-GelI-gel will be used for maintenance of airway during general anaesthesia |
| LMA ambu auraonce group | Active comparator | Device: LMALMA ambu auraonce will be used for maintenance of airway during general anaesthesia |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-GelI-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. | Device | I-Gel group |
| LMAThe 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. | Device | LMA ambu auraonce group |
Primary outcome
Frequency and severity of postoperative sore throat
Time frame: 24 hours
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 1. mild (complains of sore throat only on asking) 2. moderate (complains of sore throat on his/her own) 3. 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.
5 secondary outcomes
Immediate complications
Time frame: Immediately after removal of supraglottic device
Insertion time
Time frame: 5 minutes
Ease of insertion
Time frame: 5 minutes
Total number of attempts
Time frame: 5 minutes
Oropharyngeal seal pressure
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Background: PubMed 12066737Higgins 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.
- Background: PubMed 23833853Mokhtar 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.
- Background: PubMed 25473460Kim 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.
- Background: PubMed 21572318Theiler 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.
- Background: PubMed 19243322Beylacq 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.
- Background: PubMed 8712387Verghese 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.
- Background: PubMed 10995141McHardy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malika H Dhanani, FCPS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-Gel and LMA in people with Laryngeal Masks and Pharyngitis, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of postoperative sore throat (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140228, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.