- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380768
A Comparison of the Ambu AuraGain Versus LMA Supreme in Children
July 17, 2015 updated by: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children
The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme.
Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.
Study Type
Interventional
Enrollment (Actual)
100
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
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
-
-
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 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Scheduled for surgery utilizing a supraglottic airway device
- ASA (American Society of Anesthesiologists) I-III classification
- Weighing between 5 - 20 kilograms
Exclusion Criteria:
- Active respiratory infection
- History of difficult mask ventilation
- Diagnosis of congenital syndrome with difficult airway management
- Active gastrointestinal reflux
- Coagulopathy
- Significant Pulmonary disease
- Emergent surgery
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ambu AuraGain
Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
|
The device will be inserted and timed.
A leak pressure test will be performed after successful insertion and after 10 minutes.
The larynx will be visualized by placing a fiberoptic bronchoscope through the device.
A gastric tube will be inserted through the device and timed.
Other Names:
|
Active Comparator: LMA Supreme
Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
|
The device will be inserted and timed.
A leak pressure test will be performed after successful insertion and after 10 minutes.
The larynx will be visualized by placing a fiberoptic bronchoscope through the device.
A gastric tube will be inserted through the device and timed.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oropharyngeal (airway) leak pressure - Initial
Time Frame: Assessed intraoperatively at the time of confirmed device placement
|
The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway
|
Assessed intraoperatively at the time of confirmed device placement
|
Oropharyngeal (airway) leak pressure - 10 Minutes
Time Frame: Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
|
The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway
|
Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time for Successful Placement of the Supraglottic Airway
Time Frame: Assessed intraoperatively at the time of confirmed device placement
|
Time for successful placement of supraglottic device will be recorded
|
Assessed intraoperatively at the time of confirmed device placement
|
Number of attempts to placement of Supraglottic Airway
Time Frame: Assessed intraoperatively at the time of confirmed device placement
|
Number of attempts and insertion techniques will be recorded (maximum of 3 attempts)
|
Assessed intraoperatively at the time of confirmed device placement
|
Fiberoptic Grade of Laryngeal View through Supraglottic Airway
Time Frame: Assessed intraoperatively at the time of confirmed device placement
|
Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system
|
Assessed intraoperatively at the time of confirmed device placement
|
Gastric Tube Insertion Ease of Placement
Time Frame: Assessed intraoperatively at the time of confirmed gastric tube placement
|
The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube.
|
Assessed intraoperatively at the time of confirmed gastric tube placement
|
Gastric Tube Insertion Time
Time Frame: Assessed intraoperatively at the time of confirmed gastric tube placement
|
The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded.
Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
|
Assessed intraoperatively at the time of confirmed gastric tube placement
|
Gastric Tube Insertion Attempts
Time Frame: Assessed intraoperatively at the time of confirmed gastric tube placement
|
Number of insertion attempts of the gastric tube through the SGA will be recorded.
Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
|
Assessed intraoperatively at the time of confirmed gastric tube placement
|
Postoperative Complications
Time Frame: Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
|
Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period.
|
Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
|
Intraoperative Complications
Time Frame: Assessed intraoperatively
|
Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur.
|
Assessed intraoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Narasimhan Jagannathan, M.D., 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
- White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.
- 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, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth. 2015 Apr;25(4):334-45. doi: 10.1111/pan.12614. Epub 2015 Jan 13.
- Jagannathan N, Sohn L, Sommers K, Belvis D, Shah RD, Sawardekar A, Eidem J, Dagraca J, Mukherji I. A randomized comparison of the laryngeal mask airway supreme and laryngeal mask airway unique in infants and children: does cuff pressure influence leak pressure? Paediatr Anaesth. 2013 Oct;23(10):927-33. doi: 10.1111/pan.12145. Epub 2013 Mar 23.
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
March 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
February 26, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 5, 2015
Study Record Updates
Last Update Posted (Estimate)
July 20, 2015
Last Update Submitted That Met QC Criteria
July 17, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 2015-252
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.
Clinical Trials on Supraglottic Airway
-
The University of Texas Health Science Center,...Ambu A/SCompleted
-
Cancer Institute and Hospital, Chinese Academy...UnknownSupraglottic AirwayChina
-
The University of Texas Health Science Center,...CompletedEndotracheal Intubation | Supraglottic AirwayUnited States
-
University of MalayaUnknownGeneral Anesthesia | Supraglottic Airway Device | Laryngeal Mask Airway
-
Istanbul Medeniyet UniversityCompletedSupraglottic Airway DevicesTurkey
-
Yonsei UniversityCompletedSupraglottic Airway DeviceKorea, Republic of
-
Ann & Robert H Lurie Children's Hospital of ChicagoUnknownSupraglottic Airway Use in ChildrenUnited States
-
Universiti Kebangsaan Malaysia Medical CentreCompletedSupraglottic Airway DeviceMalaysia
-
Reham Ali Abdelhaleem AbdelrahmanCompleted
-
Cairo UniversityUnknownSupraglottic Airway DevicesEgypt
Clinical Trials on Ambu AuraGain (size 1.5 or size 2.0)
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedTracheal Intubation in ChildrenUnited States
-
Aga Khan UniversityRecruitingChild | Pediatrics | Laryngeal Masks | MinorsPakistan
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...UnknownKeratotic Nodular SizeBangladesh
-
University of MinnesotaCompleted
-
ConjuChemCompleted
-
Cosmo Technologies LtdCompletedAdenomasUnited Kingdom, United States, Italy
-
Iperboreal Pharma SrlRecruitingEnd Stage Renal DiseaseDenmark, Sweden, Italy, Spain, United Kingdom, Germany
-
Wills EyeMid Atlantic RetinaCompletedDiabetic Macular Edema | Retinal Vein Occlusion | Age Related Macular DegenerationUnited States
-
Technical University of MunichSchool of Medicine, Technical University Munich, Münchner Studienzentrum; Klinikum...RecruitingUrinary Tract Infection ChronicGermany
-
Institut de Recherches Cliniques de MontrealCompleted