A Simple Method to Determine the Size of the ProSeal LMA (PLMA) in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- the sizes of the PLMA determined with the ear-based formula
Study Overview
Brief Summary
After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. The size of the LMA was determined by choosing the size that was best matched with the auricle of the children. The results were compared with the standard method recommended by the manufacturer's weight-related guidelines. The patients were classified in different groups depending on the PLMA sizes determined by both methods. A kappa coefficient evaluated the agreement between both techniques.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- — to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA physical status I/II
- •scheduled for genitourinary operation
- •LMA was indicated for anesthesia
Exclusion Criteria
- •surgery lasting more than 3 h
- •overweight or underweight patients
- •gastroesophageal reflux
- •risk of aspiration
- •airway infection in the last six weeks
- •decreased pulmonary or chest wall compliance.
Arms & Interventions
Ear-sized based and weight based formula
the sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula
Intervention: Ear-sized based (Device)
Outcomes
Primary Outcomes
the sizes of the PLMA determined with the ear-based formula
Time Frame: One year
we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA
Secondary Outcomes
No secondary outcomes reported
Investigators
Murat Haliloglu
Medical doctor
Yeditepe University Hospital