Intubation, Intratracheal Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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