A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children
This study has been completed.
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01633073
First received: June 28, 2012
Last updated: October 1, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Laryngeal Masks in Children |
Device: LMA Supreme: control device Device: i-gel: comparison device |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
| Official Title: | A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the i-gelTM in Children |
Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Primary Outcome Measures:
- Airway Leak Pressure [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]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 Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation
- 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 ] [ Designated as safety issue: No ]The ease of gastric placement will be timed and assessed using a subjective scale
- 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 ] [ Designated as safety issue: No ]Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient
- Quality of the airway [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Assessed by the subject's response or parents subjective assesment 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 ] [ Designated as safety issue: Yes ]Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
| Enrollment: | 170 |
| Study Start Date: | June 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: LMA Supreme |
Device: LMA Supreme: control device
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 Name: laryngeal mask airway
|
| Active Comparator: i-gel |
Device: i-gel: comparison device
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 Name: laryngeal mask airway
|
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.
Eligibility| Ages Eligible for Study: | 3 Months to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633073
Locations
| United States, Illinois | |
| Ann & Robert H. Lurie Children's Hospital of Chicago | |
| Chicago, Illinois, United States, 60611 | |
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
| Principal Investigator: | Narasimhan Jagannathan, MD | Ann & Robert H Lurie Children's Hospital of Chicago |
More Information
Publications:
| Responsible Party: | Narasimhan Jagannathan, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago |
| ClinicalTrials.gov Identifier: | NCT01633073 History of Changes |
| Other Study ID Numbers: | SLMA vs i-gel |
| Study First Received: | June 28, 2012 |
| Last Updated: | October 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013