NCT02257411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
Last Updated

October 6, 2014

Status Verified

October 1, 2014

Enrollment Period

Same day

First QC Date

September 22, 2014

Last Update Submit

October 1, 2014

Conditions

Ear Based ProSeal LMA

Keywords

childear basedProseal LMA

Outcome Measures

Primary Outcomes (1)

  • the sizes of the PLMA determined with the ear-based formula

    we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA

    One year

Study Arms (1)

Ear-sized based and weight based formula

ACTIVE COMPARATOR

the sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula

Device: Ear-sized based

Interventions

Ear-sized basedDEVICE

the sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula

Ear-sized based and weight based formula

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status I/II
  • scheduled for genitourinary operation
  • LMA was indicated for anesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University Hospital

Istanbul, Kozyatağı, 34752, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

September 22, 2014

First Posted

October 6, 2014

Study Start

June 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 6, 2014

Record last verified: 2014-10

Locations

TU(1)