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Different Techniques for Emergency Cricothyroidotomy

Incision-first Versus Classic Seldinger Technique for Emergency Cricothyroidotomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01107561
Acronym
CRIC
Enrollment
50
Registered
2010-04-21
Start date
2010-04-30
Completion date
2010-07-31
Last updated
2011-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Intratracheal

Keywords

cricothyroidotomy, intubation, airway, emergency medicine, education

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.

Interventions

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

DEVICESurgical 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.

Sponsors

Canadian Association of Emergency Physicians
CollaboratorINDUSTRY
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Non-physicians

Design outcomes

Primary

MeasureTime frameDescription
Time to complete airway accessWithin the 5 minutes permitted for each procedureMeasured in seconds as the time taken for insertion of the tube and connection of the bagging device.

Secondary

MeasureTime frameDescription
SuccessWithin 5 minutes of the start of the procedureWill be confirmed by inspection of the catheter within the tracheal lumen post procedure.
Number of attemptsWithin the 5 minutes permitted for each procedureNumber of needle insertions, sweeps with blade, guide-wire insertions, dilatation attempts and catheter insertions attempts.
ComplicationsWithin the 5 minutes permitted for each procedurePenetration of posterior wall or placement of the tube outside the trachea
Perceived difficultyPrior to end of the educational sessionSelf-completed survey/questionnaire to assess level of difficulty and preference.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026