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Different Techniques for Emergency Cricothyroidotomy (CRIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01107561
First Posted: April 21, 2010
Last Update Posted: October 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Association of Emergency Physicians
Information provided by (Responsible Party):
University of Alberta
  Purpose
This educational study will examine two different techniques for training emergency residents and staff on achieving a surgical airway (called a cricothyroidotomy).

Condition Intervention
Intubation, Intratracheal Other: Seldinger technique Device: Surgical Airway Approach

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Incision-first Versus Classic Seldinger Technique for Emergency Cricothyroidotomy

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Time to complete airway access [ Time Frame: Within the 5 minutes permitted for each procedure ]
    Measured in seconds as the time taken for insertion of the tube and connection of the bagging device.


Secondary Outcome Measures:
  • Success [ Time Frame: Within 5 minutes of the start of the procedure ]
    Will be confirmed by inspection of the catheter within the tracheal lumen post procedure.

  • Number of attempts [ Time Frame: Within the 5 minutes permitted for each procedure ]
    Number of needle insertions, sweeps with blade, guide-wire insertions, dilatation attempts and catheter insertions attempts.

  • Complications [ Time Frame: Within the 5 minutes permitted for each procedure ]
    Penetration of posterior wall or placement of the tube outside the trachea

  • Perceived difficulty [ Time Frame: Prior to end of the educational session ]
    Self-completed survey/questionnaire to assess level of difficulty and preference.


Estimated Enrollment: 50
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seldinger technique
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
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 Name: Neddle approach
Active Comparator: Surgical airway approach
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
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.
Other Name: Open approach

Detailed Description:

Introduction: In patients that cannot be intubated or ventilated by conventional means an emergency cricothyroidotomy is a potentially life saving intervention that is the common final pathway of difficult airway algorithms. Significant debate surrounds the ideal method of performing an emergency cricothyroidotomy. The literature remains divided between the open (surgical) and closed (wire assisted, or Seldinger) techniques. We feel that these two methods are not mutually exclusive and are proposing a novel "incision first" modification to the traditional Seldinger closed technique. Making a small (1 cm) incision prior needle insertion could facilitate localization of landmarks and may improve speed or success rate of the closed Seldinger procedure.

Introduction: In patients that cannot be intubated or ventilated by conventional means an emergency cricothyroidotomy is a potentially life saving intervention that is the common final pathway of difficult airway algorithms. Significant debate surrounds the ideal method of performing an emergency cricothyroidotomy. The literature remains divided between the open (surgical) and closed (wire assisted, or Seldinger) techniques. We feel that these two methods are not mutually exclusive and are proposing a novel "incision first" modification to the traditional Seldinger closed technique. Making a small (1 cm) incision prior needle insertion could facilitate localization of landmarks and may improve speed or success rate of the closed Seldinger procedure.

Methods: Using concealed allocation, this randomized controlled cross-over trial will be performed in a laboratory setting. Outcome assessment will be blinded. Both staff and resident emergency physicians will be included in this trial. We will use a well-validated swine trachea model for this study.

Results: Results will be collected using standardized Case Report Forms (CRF) and independently entered into a pre-constructed Microsoft ACCESS database. The primary outcome will be time to procedure completion. Secondary outcomes will be proportion of successful cricothyroidotomy, complications and ease of procedure and ability to increase clinical confidence using this model. Paired t-tests and Fisher's exact test will be used to compare the outcomes and due to multiple statistical tests, a correction will be used to adjust for multiple tests (p < 0.025) to indicate significance.

Conclusions: This study will assess and evaluate both the incision first model and closed Seldinger cricothyroidotomy techniques. We will discuss the merits of each technique and the effectiveness of the model.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-physicians

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107561


Locations
Canada, Alberta
Department of Emergency Medicine
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Canadian Association of Emergency Physicians
Investigators
Principal Investigator: Sandy Dong, MD, MSc University of Alberta
Principal Investigator: Warren Thirsk, MD, FRCPC University of Alberta
Study Director: Brian H Rowe, MD, MSc University of Alberta
Study Director: Cristina Villa-Roel, MD, MSc University of Alberta
  More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01107561     History of Changes
Other Study ID Numbers: Pro00011192
First Submitted: April 12, 2010
First Posted: April 21, 2010
Last Update Posted: October 14, 2011
Last Verified: October 2011

Keywords provided by University of Alberta:
cricothyroidotomy
intubation
airway
emergency medicine
education

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes