NCT03411655

Brief Summary

The investigators test the hypothesis that fiberoptic intubation (time and success rate) differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

January 19, 2018

Last Update Submit

January 25, 2018

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Fiberoptic intubation

    The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)

    5 minutes

Study Arms (2)

Ambu® Aura-ITM

ACTIVE COMPARATOR
Device: Ambu® Aura-ITM

Ambu Aura GainTM

ACTIVE COMPARATOR
Device: Ambu Aura GainTM

Interventions

Ambu Aura GainTMDEVICE

Time and success rate

Ambu Aura GainTM
Ambu® Aura-ITMDEVICE

Time and success rate

Ambu® Aura-ITM

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II
  • age 1.5 - 6 years
  • minor surgery
  • extraglottic airway device

You may not qualify if:

  • age (\<18 months, \>6 years)
  • weight (\<10 kg, \>20 kg)
  • a known difficult airway
  • risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Christian Keller, MD M.Sc.

CONTACT

0041 44 3857462christian.keller@kws.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD M.Sc.

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 26, 2018

Study Start

March 1, 2018

Primary Completion

June 1, 2018

Study Completion

August 1, 2018

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share