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The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.
The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). 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, and complications will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMA Unique | Active Comparator |
| |
| LMA Supreme | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMA Unique: control device | Device | LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Airway Leak Pressure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to secure the airway | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narasimhan Jagannathan, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22420717 | Background | 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. | |
| 22416790 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 3, 2014 | |
| Reset | Mar 18, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 3, 2014 | Mar 18, 2014 |
| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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| LMA Supreme: comparison device | Device | LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, 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. |
|
|
Number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure) |
| Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Fiberoptic grade of laryngeal view | The laryngeal alignment through the devices will be graded using an established scoring system | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Gastric insufflation | The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Ease of gastric tube placement (only in patients who receive LMA Supreme) | The ease of gastric placement will be timed and assessed using a subjective scale. The LMA Unique does not contain a gastric port so this outcome will only be assessed in patients who received the LMA Supreme device. | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Quality of the airway | The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale | 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 | 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%. | Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours |
| Oropharyngolaryngeal morbidity at discharge | Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. | Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours |
| Oropharyngolaryngeal morbidity at 24 hours post-operatively | Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. | Measured at 24 hours after device placement/study initiation |
| 22070630 | Background | 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. |
| 22352745 | Background | 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. |
| 22151106 | Background | 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. |
| 21883132 | Background | 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. |
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |