Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks

Airway Management Clinical Trial

Official title:

A Comparison of Ultrasound Versus Digital Palpation Guided Cricothyrotomy in Subjects With Poorly Defined Anatomical Landmarks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475487
• Other study ID #: CUS-2010
• Status: Completed
• Phase: N/A
• First received: November 3, 2011
• Last updated: June 24, 2015
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: June 2015
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Airway Management

Intervention

Procedure:
• Utrasound guided cricothyrotomy
Utrasound guided cricothyrotomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries	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)).	On avergae less than 300 seconds	No
Secondary	Insertion Time	Defined as palpation of the skin to completion of procedure- cannula in trachea.	less than 5 minutes from starting of procedure	Yes
Secondary	Number of Attempts	Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.	not more than 300 seconds	No
Secondary	Correct Landmarking	Correct landmarking by all participants between the ultrasound and digital palpation group	less than 300 seconds	No