NCT02708043

Brief Summary

The current study retrospectively assesses laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
814

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

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, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

3.4 years

First QC Date

February 21, 2016

Last Update Submit

March 9, 2016

Conditions

Adenoidectomy SurgeryFlexible-Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

  • The incidence of failed LMA (0=failed, 1=good)

    3 year

Secondary Outcomes (1)

  • Surgeon satisfaction level (0=bad, 1=same, 2=good)

    3 year

Study Arms (1)

F-LMA group

OTHER

LMA were placed to 814 patients for adenoidectomy surgery. Researchers evaluated flexible laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.

Other: Flexible-Laryngeal Mask Airway

Interventions

Flexible-Laryngeal Mask AirwayOTHER
F-LMA group

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • ASA I-II
  • Scheduled for elective adenoidectomy under general anesthesia with F-LMA between June 2012 and November 2015.

You may not qualify if:

  • Emergency
  • Extreme obesity
  • Sign of clinical significant infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 21, 2016

First Posted

March 15, 2016

Study Start

June 1, 2012

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

March 15, 2016

Record last verified: 2016-03