NCT02382887

Brief Summary

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery. Commonly, the management of the tracheal intubation is performed by a fiberoptic technique. However, changes in equipment availability and quality may challenge the fiberoptic intubation technique. The investigators wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 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

March 1, 2009

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

8.4 years

First QC Date

March 3, 2015

Last Update Submit

December 29, 2017

Conditions

Spinal Injuries

Keywords

intubationdifficult airwayfiberscopyAirtraqgeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Neuromonitoring modifications (modifications appearing on the neuromonitoring)

    modifications appearing on the neuromonitoring during the 5 different phases

    30 seconds

Secondary Outcomes (3)

  • time necessary for tracheal intubation

    180 seconds

  • tracheal inlet view (best view during intubation)

    10 seconds

  • number of attempts necessary

    180 seconds

Study Arms (2)

Tracheal intubation with Fiberscopy

ACTIVE COMPARATOR

tracheal intubation with a fiberscope

Procedure: tracheal intubationDevice: fiberscope

Tracheal intubation with Airtraq

EXPERIMENTAL

tracheal intubation with an Airtraq

Procedure: tracheal intubationDevice: Airtraq

Interventions

tracheal intubationPROCEDURE

tracheal intubation with the Airtraq

Tracheal intubation with AirtraqTracheal intubation with Fiberscopy
AirtraqDEVICE
Tracheal intubation with Airtraq
fiberscopeDEVICE
Tracheal intubation with Fiberscopy

Eligibility Criteria

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

You may qualify if:

  • unstable cervical spine due to a cervical vertebra fracture
  • American Society of Anesthesia classification 1-3
  • BMI \< 30 kg/m2
  • patients necessitating a general anesthesia for surgery

You may not qualify if:

  • patient refusal
  • ASA \>3
  • mouth opening \< 15mm
  • patients with known history of previous orotracheal tumor surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of Anesthesiology, University of Lausanne CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Spinal Injuries

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Back InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Patrick Schoettker, MD, PD

    Chief Medical Officer

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 9, 2015

Study Start

March 1, 2009

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 2, 2018

Record last verified: 2017-12

Locations

CH(1)