Children
Conditions
Keywords
supraglottic airway devices in children
Brief summary
The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. 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 (airway related, gastric insufflation, trauma) will also be assessed.
Detailed description
The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique. Both models are approved for use by the FDA, and are routinely used for airway management during general anesthesia. Three main features distinguish the laryngeal mask airway Supreme from the original LMA: i) a curved rigid airway tube, ii) provision for a gastric drain tube, and iii) a larger mask for improved fit and airway seal. The aim of this randomized prospective study is to compare two types of the laryngeal mask airway: the laryngeal mask airway Unique and the laryngeal mask airway Supreme, in pediatric patients without the use of neuromuscular blockade. Based on the design features listed above, we hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. 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 (airway related, gastric insufflation, trauma) will also be assessed.
Interventions
None listed
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Children undergoing general anesthesia using a supraglottic airway device * weight 10-25kg * age 6 months-6 years
Exclusion criteria
ASA class IV, V Emergency procedures * History of a difficult airway * Active gastrointestinal reflux * Active upper respiratory tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway leak pressure | after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively | 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 completely. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | Participants will be followed 24 hours postoperatively | complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded |
| Time to secure the airway | after placement of the supraglottic airway device | From picking up the airway device to bilateral chest expansion and presence of ETCO2 |
| Number of attempts to place the device | at the beginning of anesthesia | number of attempts needed for successful placement will be recorde (maximum of 3 attempts will be considered as a failure) |
| Fiberoptic grade of laryngeal view | After placement of the supraglottic device | The laryngeal alignment through the devices will be graded using an established scoring system |
| Ease of gastric tube placement | After placement of the LMA supreme | The ease of gastric placement will be assessed using a subjective scale |
| Gastric insufflation | During leak pressure testing | The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation |
| Quality of the airway | During maintenance of anesthesia | The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale |
| Fiberoptic view through the gastric tube | After placement of the LMA supreme | The view through the gastric drain tube of the LMA supreme will be assessed and graded using an established scoring system |
Countries
United States
Outcome results
None listed