NCT02811042

Brief Summary

The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.

Trial Health

47
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 Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

June 14, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

June 14, 2016

Last Update Submit

June 20, 2016

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

  • oropharyngeal leak pressure

    5 min

Secondary Outcomes (1)

  • fiberoptic position

    5 min

Study Arms (2)

Oropharyngeal leak pressure

ACTIVE COMPARATOR

Ambu AuraOnce

Device: Ambu AuraOnce

Fiberoptic position

EXPERIMENTAL

Ambu AuraGain

Device: Ambu AuraGain

Interventions

Ambu AuraOnceDEVICE

Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

Oropharyngeal leak pressure
Ambu AuraGainDEVICE

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)

Fiberoptic position

Eligibility Criteria

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

You may qualify if:

  • ASA I-II
  • age 1 - 16 years
  • minor surgery
  • extraglottic airway device

You may not qualify if:

  • age (\<12 months, \>16 years)
  • weight (\<12 kg, \>50 kg)
  • a known difficult airway
  • risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zentralkrankenhaus Bozen

Bolzano, 39100, Italy

Location

Christian Keller MD, M.Sc.

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Stogermuller B, Ofner S, Ziegler B, Keller C, Moser B, Gasteiger L. Ambu(R) Aura Gain versus Ambu(R) Aura Once in children: a randomized, crossover study assessing oropharyngeal leak pressure and fibreoptic position. Can J Anaesth. 2019 Jan;66(1):57-62. doi: 10.1007/s12630-018-1235-7. Epub 2018 Oct 12.

    PMID: 30315506DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. M.Sc.

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 23, 2016

Study Start

July 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

June 23, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)CH(1)