Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks
- Conditions
- Airway Management
- Interventions
- Procedure: Utrasound guided cricothyrotomy
- Registration Number
- NCT01475487
- Lead Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Residents who are novice to the application of ultrasound in difficult airway scenarios
- Cadavers with difficult and imposible landmarks identification
- Anethesiologist with previous experience in CT, manual or ultrasound assisted
- Patients with easily identifiable landmarks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound guided cricothyrotomy group Utrasound guided cricothyrotomy Group-2 Ultrasound guided cricothyrotomy Cricothyrotomy using Digital Palpation Utrasound guided cricothyrotomy Group-1 will perform Cricothyrotomy using conventional digital palpation technique
- Primary Outcome Measures
Name Time Method The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries On avergae less than 300 seconds 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)).
- Secondary Outcome Measures
Name Time Method Number of Attempts not more than 300 seconds Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.
Correct Landmarking less than 300 seconds Correct landmarking by all participants between the ultrasound and digital palpation group
Insertion Time less than 5 minutes from starting of procedure Defined as palpation of the skin to completion of procedure- cannula in trachea.