Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway
Conditions
Keywords
LMA Supreme, i-gel, supraglottic airway
Brief summary
Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.
Interventions
DEVICEI gel
DEVICELMA Supreme
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
1\. Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Exclusion criteria
1\. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| airway leak pressure | within 5 min of insertion of each device | Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 30 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached. |
Countries
South Korea
Contacts
Primary ContactJeong-Rim LEE, MD
Outcome results
None listed