Clinical trial NCT01475487: Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks
Official title: A Comparison of Ultrasound Versus Digital Palpation Guided Cricothyrotomy in Subjects With Poorly Defined Anatomical Landmarks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Inability to provide oxygen to the patient remains the most fearful anesthesia-related mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an anesthesiologist, who is encountered with this situation. The current method of cricothyrotomy relies on digital palpation (DP). Several patient populations, including morbidly obese, short neck, radiation to and previous neck surgeries, have difficult landmarks for this procedure. Ultrasound (US) technology has been used in the past to visualize landmarks for cricothyrotomy, but there is no study which has examined the role of ultrasound in patients who have obscure landmarks. There is no data related to the performance of ultrasound guided cricothyrotomy in these patients. In this study, we aimed to determine the outcomes of CT performed on human cadavers using US-guidance, compared to conventional DP, of anatomical landmarks. In particularly, complication rates, failure to cannulate, correct placement of the device and insertion time of CT were assessed.

Detailed description: For each cadaver - epidemiological data (age, sex) and morphometric data (Body Mass Index, neck circumference, thyromental distance)

The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (\< 5 mm laceration); moderate (\> 5mm laceration or partial puncture); severe (\> 10 mm laceration or full puncture)). For clinical relevance and analysis of data we dichotomized the scale to none-mild and moderate - severe injuries.

The secondary outcomes include: 1) insertion time, measured in seconds (s) from the time of palpation of the skin to insertion of the Portex device in the trachea; 2) failure, with a 'failure' defined as any attempt in which the trachea was not cannulated, or which required \> 300 s to perform; and 3) correct land-marking, defined as having the Portex device inserted via the CM.

Eligibility criteria: Inclusion Criteria:

* Residents who are novice to the application of ultrasound in difficult airway scenarios
* Cadavers with difficult and imposible landmarks identification

Exclusion Criteria:

* Anethesiologist with previous experience in CT, manual or ultrasound assisted
* Patients with easily identifiable landmarks

Primary outcomes:
measure: The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
timeFrame: On avergae less than 300 seconds
Secondary outcomes:
measure: Insertion Time
timeFrame: less than 5 minutes from starting of procedure
measure: Number of Attempts
timeFrame: not more than 300 seconds
measure: Correct Landmarking
timeFrame: less than 300 seconds
Other outcomes:
Locations:
Study officials:
affiliation: Mount Sinai Hospital Department of Anesthesia and Pain Management
name: Naveed Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References: