Clinical trial NCT01107561: Different Techniques for Emergency Cricothyroidotomy
Official title: Incision-first Versus Classic Seldinger Technique for Emergency Cricothyroidotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Keywords: cricothyroidotomy
intubation
airway
emergency medicine
education
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Association of Emergency Physicians
First posted: 2010-04-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Non-physicians

Primary outcomes:
measure: Time to complete airway access
timeFrame: Within the 5 minutes permitted for each procedure
Secondary outcomes:
measure: Success
timeFrame: Within 5 minutes of the start of the procedure
measure: Number of attempts
timeFrame: Within the 5 minutes permitted for each procedure
measure: Complications
timeFrame: Within the 5 minutes permitted for each procedure
measure: Perceived difficulty
timeFrame: Prior to end of the educational session
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Department of Emergency Medicine
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sandy Dong, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Warren Thirsk, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Brian H Rowe, MD, MSc
role: STUDY_DIRECTOR
affiliation: University of Alberta
name: Cristina Villa-Roel, MD, MSc
role: STUDY_DIRECTOR
References: