NCT01467739

Brief Summary

The purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for tracheal intubation in difficult airways due to cervical immobilization by a cervical collar, and compare it to a conventional reusable fiberscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 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

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

November 8, 2011

Last Update Submit

December 13, 2013

Conditions

Surgical InterventionEndotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of the Ambu ® aScope® for tracheal intubation in difficult airways.

    Time to reach the carina and Time to obtain an end tidal CO2 curve by aScope in comparison to conventional reusable fiberscope.

Study Arms (2)

Ambu ® aScope®

ACTIVE COMPARATOR
Device: Ambu ® aScope®

a conventional reusable fiberscope.

ACTIVE COMPARATOR
Device: a conventional reusable fiberscope

Interventions

Ambu ® aScope®DEVICE
Ambu ® aScope®
a conventional reusable fiberscopeDEVICE
a conventional reusable fiberscope.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 16 years
  • ASA 1-2
  • BMI \< 35 kg/m2
  • Surgery requiring general anesthesia with intubation of the trachea

You may not qualify if:

  • Emergency operation
  • Patient ASA 3 or more
  • BMI above 35 kg/m2
  • History of difficult airways
  • History of surgery or radiotherapy in head and neck
  • Presence of gastro esophageal reflux

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • Krugel V, Bathory I, Frascarolo P, Schoettker P. Comparison of the single-use Ambu((R)) aScope 2 vs the conventional fibrescope for tracheal intubation in patients with cervical spine immobilisation by a semirigid collar*. Anaesthesia. 2013 Jan;68(1):21-6. doi: 10.1111/anae.12044. Epub 2012 Oct 22.

    PMID: 23088837RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 9, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

CH(1)