NCT01692522

Brief Summary

The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

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

September 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

1.8 years

First QC Date

September 17, 2012

Last Update Submit

August 14, 2014

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

  • First attempt visualized blind intubation success rate

    how many seconds needed

Secondary Outcomes (1)

  • Overall intubation success rate

    how many seconds needed

Study Arms (2)

Ambu Aura-i

EXPERIMENTAL

intubation

Procedure: Intubation

AirQ

ACTIVE COMPARATOR

intubation

Procedure: Intubation

Interventions

IntubationPROCEDURE

visualized blind intubation

AirQAmbu Aura-i

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years
  • max 50kg
  • ASA I-III

You may not qualify if:

  • risk of aspiration
  • known difficult airway
  • congenital malformations respiratory tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University Hospital

Bern, Canton of Bern, Switzerland

Location

Related Publications (1)

  • Kleine-Brueggeney M, Nicolet A, Nabecker S, Seiler S, Stucki F, Greif R, Theiler L. Blind intubation of anaesthetised children with supraglottic airway devices AmbuAura-i and Air-Q cannot be recommended: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):631-9. doi: 10.1097/EJA.0000000000000261.

    PMID: 26061874DERIVED

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Robert Greif, MD MME FERC

    University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 25, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations

CH(1)