Different Techniques for Emergency Cricothyroidotomy (CRIC)
Primary Purpose
Intubation, Intratracheal
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Seldinger technique
Surgical Airway Approach
Sponsored by

About this trial
This is an interventional treatment trial for Intubation, Intratracheal focused on measuring cricothyroidotomy, intubation, airway, emergency medicine, education
Eligibility Criteria
Inclusion Criteria:
All staff and residents presenting to a airway lab for Informed verbal consent.
Exclusion Criteria:
Non-physicians
Sites / Locations
- Department of Emergency Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Seldinger technique
Surgical airway approach
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time to complete airway access
Measured in seconds as the time taken for insertion of the tube and connection of the bagging device.
Secondary Outcome Measures
Success
Will be confirmed by inspection of the catheter within the tracheal lumen post procedure.
Number of attempts
Number of needle insertions, sweeps with blade, guide-wire insertions, dilatation attempts and catheter insertions attempts.
Complications
Penetration of posterior wall or placement of the tube outside the trachea
Perceived difficulty
Self-completed survey/questionnaire to assess level of difficulty and preference.
Full Information
NCT ID
NCT01107561
First Posted
April 12, 2010
Last Updated
October 13, 2011
Sponsor
University of Alberta
Collaborators
Canadian Association of Emergency Physicians
1. Study Identification
Unique Protocol Identification Number
NCT01107561
Brief Title
Different Techniques for Emergency Cricothyroidotomy
Acronym
CRIC
Official Title
Incision-first Versus Classic Seldinger Technique for Emergency Cricothyroidotomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canadian Association of Emergency Physicians
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation, Intratracheal
Keywords
cricothyroidotomy, intubation, airway, emergency medicine, education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Seldinger technique
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgical airway approach
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Seldinger technique
Other Intervention Name(s)
Neddle approach
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Surgical Airway Approach
Other Intervention Name(s)
Open approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to complete airway access
Description
Measured in seconds as the time taken for insertion of the tube and connection of the bagging device.
Time Frame
Within the 5 minutes permitted for each procedure
Secondary Outcome Measure Information:
Title
Success
Description
Will be confirmed by inspection of the catheter within the tracheal lumen post procedure.
Time Frame
Within 5 minutes of the start of the procedure
Title
Number of attempts
Description
Number of needle insertions, sweeps with blade, guide-wire insertions, dilatation attempts and catheter insertions attempts.
Time Frame
Within the 5 minutes permitted for each procedure
Title
Complications
Description
Penetration of posterior wall or placement of the tube outside the trachea
Time Frame
Within the 5 minutes permitted for each procedure
Title
Perceived difficulty
Description
Self-completed survey/questionnaire to assess level of difficulty and preference.
Time Frame
Prior to end of the educational session
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All staff and residents presenting to a airway lab for Informed verbal consent.
Exclusion Criteria:
Non-physicians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy Dong, MD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Warren Thirsk, MD, FRCPC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian H Rowe, MD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cristina Villa-Roel, MD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Study Director
Facility Information:
Facility Name
Department of Emergency Medicine
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
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Different Techniques for Emergency Cricothyroidotomy
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