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Different Techniques for Emergency Cricothyroidotomy

Not Applicable
Completed
Conditions
Intubation, Intratracheal
Interventions
Other: Seldinger technique
Device: Surgical Airway Approach
Registration Number
NCT01107561
Lead Sponsor
University of Alberta
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria

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

Exclusion Criteria

Non-physicians

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Seldinger techniqueSeldinger techniqueInvolves 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.
Surgical airway approachSurgical Airway ApproachThe 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.
Primary Outcome Measures
NameTimeMethod
Time to complete airway accessWithin 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
NameTimeMethod
SuccessWithin 5 minutes of the start of the procedure

Will be confirmed by inspection of the catheter within the tracheal lumen post procedure.

Number of attemptsWithin the 5 minutes permitted for each procedure

Number of needle insertions, sweeps with blade, guide-wire insertions, dilatation attempts and catheter insertions attempts.

ComplicationsWithin the 5 minutes permitted for each procedure

Penetration of posterior wall or placement of the tube outside the trachea

Perceived difficultyPrior to end of the educational session

Self-completed survey/questionnaire to assess level of difficulty and preference.

Trial Locations

Locations (1)

Department of Emergency Medicine

🇨🇦

Edmonton, Alberta, Canada

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