Different Techniques for Emergency Cricothyroidotomy

Intubation, Intratracheal Clinical Trial

— CRIC  

Official title:

Incision-first Versus Classic Seldinger Technique for Emergency Cricothyroidotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107561
• Other study ID #: Pro00011192
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: October 13, 2011
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: October 2011
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Non-physicians

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Intubation, Intratracheal

Intervention

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

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.

Locations

Country	Name	City	State
Canada	Department of Emergency Medicine	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Association of Emergency Physicians

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Success	Will be confirmed by inspection of the catheter within the tracheal lumen post procedure.	Within 5 minutes of the start of the procedure	No
Secondary	Number of attempts	Number of needle insertions, sweeps with blade, guide-wire insertions, dilatation attempts and catheter insertions attempts.	Within the 5 minutes permitted for each procedure	No
Secondary	Complications	Penetration of posterior wall or placement of the tube outside the trachea	Within the 5 minutes permitted for each procedure	Yes
Secondary	Perceived difficulty	Self-completed survey/questionnaire to assess level of difficulty and preference.	Prior to end of the educational session	No