NCT01107561

Brief Summary

This educational study will examine two different techniques for training emergency residents and staff on achieving a surgical airway (called a cricothyroidotomy).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 14, 2011

Status Verified

October 1, 2011

Enrollment Period

1 month

First QC Date

April 12, 2010

Last Update Submit

October 13, 2011

Conditions

Keywords

cricothyroidotomyintubationairwayemergency medicineeducation

Outcome Measures

Primary Outcomes (1)

  • Time to complete airway access

    Measured in seconds as the time taken for insertion of the tube and connection of the bagging device.

    Within the 5 minutes permitted for each procedure

Secondary Outcomes (4)

  • Success

    Within 5 minutes of the start of the procedure

  • Number of attempts

    Within the 5 minutes permitted for each procedure

  • Complications

    Within the 5 minutes permitted for each procedure

  • Perceived difficulty

    Prior to end of the educational session

Study Arms (2)

Seldinger technique

EXPERIMENTAL

Involves blind needle insertion through the skin into the cricoid membrane followed by insertion of the guide-wire and subsequent insertion of the tube over the guidewire.

Other: Seldinger technique

Surgical airway approach

ACTIVE COMPARATOR

The classical open or surgical technique involves a vertical skin incision with blunt dissection and identification of the anatomy followed by incision of the cricoid membrane and tube insertion.

Device: Surgical Airway Approach

Interventions

Involves blind needle insertion through the skin into the cricoid membrane followed by insertion of the guide-wire and subsequent insertion of the tube over the guidewire

Also known as: Neddle approach
Seldinger technique

The classical open or surgical technique involves a vertical skin incision with blunt dissection and identification of the anatomy followed by incision of the cricoid membrane and tube insertion.

Also known as: Open approach
Surgical airway approach

Eligibility Criteria

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

You may qualify if:

  • All staff and residents presenting to a airway lab for Informed verbal consent.

You may not qualify if:

  • Non-physicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency Medicine

Edmonton, Alberta, Canada

Location

Study Officials

  • Sandy Dong, MD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR
  • Warren Thirsk, MD, FRCPC

    University of Alberta

    PRINCIPAL INVESTIGATOR
  • Brian H Rowe, MD, MSc

    University of Alberta

    STUDY DIRECTOR
  • Cristina Villa-Roel, MD, MSc

    University of Alberta

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 21, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2010

Study Completion

July 1, 2010

Last Updated

October 14, 2011

Record last verified: 2011-10

Locations