Different Techniques for Emergency Cricothyroidotomy (CRIC)

Incision-first Versus Classic Seldinger Technique 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).

Study Overview

• Status: Completed
• Conditions: Intubation, Intratracheal
• Intervention / Treatment: Other: Seldinger technique; Device: Surgical Airway 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Department of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Non-physicians

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Open approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success	Will be confirmed by inspection of the catheter within the tracheal lumen post procedure.	Within 5 minutes of the start of the procedure
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
Complications	Penetration of posterior wall or placement of the tube outside the trachea	Within the 5 minutes permitted for each procedure
Perceived difficulty	Self-completed survey/questionnaire to assess level of difficulty and preference.	Prior to end of the educational session

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 21, 2010

Study Record Updates

• Last Update Posted (Estimate): October 14, 2011
• Last Update Submitted That Met QC Criteria: October 13, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: education; intubation; airway; emergency medicine; cricothyroidotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: Pro00011192