NCT03571295

Brief Summary

The investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

May 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

May 22, 2018

Last Update Submit

August 24, 2021

Conditions

Airway ManagementVideolaryngoscopy

Keywords

pediatric airway managementlearning curve

Outcome Measures

Primary Outcomes (1)

  • first attempt success rate of endotracheal intubation

    yes/no

    operation day

Secondary Outcomes (1)

  • total time for successful intubation

    operation day

Other Outcomes (1)

  • failure category of the first attempt

    operation day

Study Arms (2)

videolaryngoscopy

EXPERIMENTAL
Device: King Vision aBlade

direct laryngoscopy

EXPERIMENTAL
Device: direct laryngoscopy

Interventions

King Vision aBladeDEVICE

endotracheal intubation performed with King Vision aBlade

videolaryngoscopy
direct laryngoscopyDEVICE

endotracheal intubation performed with direct laryngoscopy

direct laryngoscopy

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA 1 to 2
  • written informed consent from both legal guardians
  • children who were scheduled for nonemergency surgery with requirement of endotracheal intubation

You may not qualify if:

  • known or predicted difficult airway
  • increased risk for pulmonary aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 27, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2020

Study Completion

September 1, 2020

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

DE(1)