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Different Techniques for Emergency Cricothyroidotomy (CRIC)

This study has been completed.
Sponsor:
Collaborator:
Canadian Association of Emergency Physicians
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01107561
First received: April 12, 2010
Last updated: October 13, 2011
Last verified: October 2011

April 12, 2010
October 13, 2011
April 2010
May 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01107561 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Different Techniques for Emergency Cricothyroidotomy
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Intubation, Intratracheal
  • 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
  • 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
  • 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.
    Intervention: Other: Seldinger technique
  • 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.
    Intervention: Device: Surgical Airway Approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Non-physicians

Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01107561
Pro00011192
No
University of Alberta
University of Alberta
Canadian Association of Emergency Physicians
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
University of Alberta
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP