NCT02572232

Brief Summary

The purpose of the study is to compare three supraglottic airway devices (Combitube, Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway scenario in a pediatric manikin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

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

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

October 6, 2015

Last Update Submit

August 15, 2018

Conditions

Airway MorbidityEmergencies

Outcome Measures

Primary Outcomes (1)

  • Time to successful ventilation

    1 min

Secondary Outcomes (4)

  • Success rate

    1 min

  • Rating of the device (questionnaire)

    1 min

  • Re-assessment of success rate after 3 months

    3 months

  • Re-assessment of time to successful ventilation after 3 months

    3 months

Study Arms (1)

Combitube, Easytube, Laryngeal masks

EXPERIMENTAL

Combitube, Easytube, Laryngeal mask airway are intubated in pediatric airway manikins by probands in randomized order.

Device: Combitube, Easytube, Laryngeal masks

Interventions

Combitube, Easytube, Laryngeal masksDEVICE

Supraglottic airway device

Combitube, Easytube, Laryngeal masks

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pediatricians
  • residents
  • interns
  • written informed consent form

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergencies

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Michael Frass, Prof. Dr.

    Medical University of Vienna

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.Prof.Dr.

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 16, 2018

Record last verified: 2018-08