Different Techniques for Emergency Cricothyroidotomy (CRIC)
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Incision-first Versus Classic Seldinger Technique for Emergency Cricothyroidotomy |
- Time to complete airway access [ Time Frame: Within the 5 minutes permitted for each procedure ] [ Designated as safety issue: No ]Measured in seconds as the time taken for insertion of the tube and connection of the bagging device.
- Success [ Time Frame: Within 5 minutes of the start of the procedure ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Penetration of posterior wall or placement of the tube outside the trachea
- Perceived difficulty [ Time Frame: Prior to end of the educational session ] [ Designated as safety issue: No ]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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All staff and residents presenting to a airway lab for Informed verbal consent.
Exclusion Criteria:
Non-physicians
Contacts and Locations| Canada, Alberta | |
| Department of Emergency Medicine | |
| Edmonton, Alberta, Canada | |
| 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
No publications provided
| Responsible Party: | University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01107561 History of Changes |
| Other Study ID Numbers: | Pro00011192 |
| Study First Received: | April 12, 2010 |
| Last Updated: | October 13, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Alberta:
|
cricothyroidotomy intubation airway emergency medicine education |
Additional relevant MeSH terms:
|
Emergencies Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013