A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children

Not Applicable

Completed

• Conditions: Laryngeal Masks in Children

• Registration Number: NCT01633073
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Airway Leak Pressure	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 Outcome Measures

Name	Time	Method
Time to secure the airway	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	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	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	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	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
Feasibility of positive pressure ventilation	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
Quality of the airway	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	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	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 assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Oropharyngolaryngeal morbidity at 24 hours post-operatively	Measured at 24 hours after device placement/study initiation	Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States