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OpenTrials
Completed

NCT Number: NCT01107561

Different Techniques for Emergency Cricothyroidotomy

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Emergency Medicine

Edmonton, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Non-physicians

Treatment and study plan

Seldinger technique

Other

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 names: Neddle approach

Surgical Airway Approach

Device

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 names: Open approach

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. Complications

    Time frame: Within the 5 minutes permitted for each procedure

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

  4. Perceived difficulty

    Time frame: Prior to end of the educational session

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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Association of Emergency Physicians

Registry information

Official study title

Incision-first Versus Classic Seldinger Technique for Emergency Cricothyroidotomy

Acronym: CRIC

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 21, 2010
Registry last updated
Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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