Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks

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

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Procedure: Utrasound guided cricothyrotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cricothyrotomy using Digital Palpation; Group-1 will perform Cricothyrotomy using conventional digital palpation technique	Procedure: Utrasound guided cricothyrotomy; Utrasound guided cricothyrotomy
EXPERIMENTAL: Ultrasound guided cricothyrotomy group; Group-2 Ultrasound guided cricothyrotomy	Procedure: Utrasound guided cricothyrotomy; Utrasound guided cricothyrotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion Time	Defined as palpation of the skin to completion of procedure- cannula in trachea.	less than 5 minutes from starting of procedure
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
Correct Landmarking	Correct landmarking by all participants between the ultrasound and digital palpation group	less than 300 seconds

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Naveed Siddiqui, MD, Mount Sinai Hospital Department of Anesthesia and Pain Management

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: November 3, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (ESTIMATE): November 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CUS-2010