Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Completed
NCT Number: NCT01653795
A Comparison of the Laryngeal Mask Airway (LMA) - Unique and LMA-Supreme in Children
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.
Completed
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Notify MeKey information
Conditions
Age range
3 month–11 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Children undergoing general anesthesia using a supraglottic airway device
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)
Treatment and study plan
LMA Unique: control device
DeviceLMA 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.
Other names: Laryngeal Mask Airway
LMA Supreme: comparison device
DeviceLMA 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.
Other names: Laryngeal Mask Airway
Primary outcomes
-
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.
Secondary outcomes
-
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
-
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)
-
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
-
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
-
Ease of gastric tube placement (only in patients who receive LMA Supreme)
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. The LMA Unique does not contain a gastric port so this outcome will only be assessed in patients who received the LMA Supreme device.
-
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
-
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
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%.
-
Oropharyngolaryngeal morbidity at discharge
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
-
Oropharyngolaryngeal morbidity at 24 hours post-operatively
Time frame: Measured at 24 hours after device placement/study initiation
Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Sponsors and collaborators
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Registry information
Official study title
A Randomized Trial Comparing the Laryngeal Mask Airway-Unique and Laryngeal Mask Airway-Supreme in Children
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jul 31, 2012
- Registry last updated
- Nov 20, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.