- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633073
A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children
October 1, 2012 updated by: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the i-gelTM in Children
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation.
The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The goal of this study is to compare the LMA Supreme and i-gel in children having surgery.
The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.
Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached.
The ease of placement, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children undergoing general anesthesia using a supraglottic airway device
- weight 5-50 kg
- age 3 months-11 years
Exclusion Criteria:
- ASA class IV, V Emergency procedures
- active respiratory infection
- known history of difficult mask ventilation
- a diagnosis of a congenital syndrome associated with difficult airway management
- airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
- active gastrointestinal reflux
- coagulopathy
- clinically significant pulmonary disease(s)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LMA Supreme
|
LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization.
One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0.
The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Other Names:
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Active Comparator: i-gel
|
i-gel will be placed in children weighing 5-50kg based on a computer generated randomization.
One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0.
The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Airway Leak Pressure
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed.
|
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to secure the airway
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
From picking up the airway device to bilateral chest expansion and presence of ETCO2
|
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Number of attempts to place the device
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)
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Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Fiberoptic grade of laryngeal view
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
The laryngeal alignment through the devices will be graded using an established scoring system
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Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Gastric insufflation
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation
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Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Ease of gastric tube placement
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
The ease of gastric placement will be timed and assessed using a subjective scale
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Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Feasibility of positive pressure ventilation
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Peak inspiratory pressure and tidal volumes will be recorded.
Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient
|
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Quality of the airway
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale
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Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
|
Incidence of device repositioning and/or replacement
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
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Intra-operative device repositioning or replacement of the device due to excessive air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor that leads to a decrease in oxygen saturation by pulse oximetry to less than 90%.
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Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
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Oropharyngolaryngeal morbidity at discharge
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
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Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
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Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
|
Oropharyngolaryngeal morbidity at 24 hours post-operatively
Time Frame: Measured at 24 hours after device placement/study initiation
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Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
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Measured at 24 hours after device placement/study initiation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Narasimhan Jagannathan, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.
- Jagannathan N, Sohn LE, Chang E, Sawardekar A. A cohort evaluation of the laryngeal mask airway-Supreme in children. Paediatr Anaesth. 2012 Aug;22(8):759-64. doi: 10.1111/j.1460-9592.2012.03832.x. Epub 2012 Mar 15.
- Jagannathan N, Sohn LE, Sawardekar A, Chang E, Langen KE, Anderson K. A randomised trial comparing the laryngeal mask airway Supreme with the laryngeal mask airway Unique in children. Anaesthesia. 2012 Feb;67(2):139-44. doi: 10.1111/j.1365-2044.2011.06960.x. Epub 2011 Nov 9.
- Lee JR, Kim MS, Kim JT, Byon HJ, Park YH, Kim HS, Kim CS. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children. Anaesthesia. 2012 Jun;67(6):606-11. doi: 10.1111/j.1365-2044.2012.07072.x. Epub 2012 Feb 21.
- Goyal R, Shukla RN, Kumar G. Comparison of size 2 i-gel supraglottic airway with LMA-ProSeal and LMA-Classic in spontaneously breathing children undergoing elective surgery. Paediatr Anaesth. 2012 Apr;22(4):355-9. doi: 10.1111/j.1460-9592.2011.03757.x. Epub 2011 Dec 8.
- Beringer RM, Kelly F, Cook TM, Nolan J, Hardy R, Simpson T, White MC. A cohort evaluation of the paediatric i-gel() airway during anaesthesia in 120 children. Anaesthesia. 2011 Dec;66(12):1121-6. doi: 10.1111/j.1365-2044.2011.06884.x. Epub 2011 Sep 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
June 28, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (Estimate)
July 4, 2012
Study Record Updates
Last Update Posted (Estimate)
October 2, 2012
Last Update Submitted That Met QC Criteria
October 1, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- SLMA vs i-gel
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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