Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Accuracy of Ultrasound of Identification of Cricothyroid Membrane.A Randomized Control Trial.

This study has been completed.
Information provided by (Responsible Party):
Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital Identifier:
First received: November 9, 2012
Last updated: November 17, 2014
Last verified: November 2014

Routine surgery requires artificial breathing through the placement of a plastic tube into the patient's windpipe via mouth or nose. This tube serves as the source of providing oxygen to the patients during surgery. Difficulties during insertion of this tube may lead to serious complications and during this life-threatening crisis the only way to provide oxygen to the patient is by the help of a procedure called cricothyrodotomy (CTY).

CTY is a live saving procedure that involves an incision on the patient neck at a very precise location called Cricothyroid Membrane (CTM). The current method of identifying this location is by palpation of neck cartilages by the operator. The incorrect identification of the CTM could lead to many complications. In certain patients such as obese or distorted neck features would make the identification of CTM difficult. Ultrasound (US) has improved the success rate of many anesthesia procedures .Its use has been described for identification of neck structures however, this technique of localization has not been validated against the gold standard which is the use of CT scan. The purpose of our study is to determine the precision of identifying the CTM using the US versus the conventional finger palpation when compared to the gold standard.

Condition Intervention
Difficult Breathing
Device: Ultrasongraphy
Other: Palpation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Accuracy of Ultrasound Compared to Conventional Methods of Identification of Cricothyroid Membrane in Subjects With Poorly Defined Neck Landmarks. A Randomized Control Trial.

Resource links provided by NLM:

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • The Measured Distance between point A & B(in millimeters). [ Time Frame: 5 minutes ]
    The distance measured in (mm) between the two points. Point A which is the center of CTM as marked by using US or digital palpation and point B which is the center of CTM as calculated on the CT image.

Secondary Outcome Measures:
  • Time taken for identification of CTM by US. [ Time Frame: 60 Seconds ]
    Defined as time from start scanning of the neck to the placing of the sticker

Other Outcome Measures:
  • Time taken for identification of CTM by Palpation. [ Time Frame: 60 Seconds. ]
    Defined as palpation of the skin to the placing of the sticker.

Enrollment: 227
Study Start Date: October 2012
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palpation group
Palpation group will consist of 107 patients, who's CTM will be marked using traditional palpation technique of identifying the Cricothyroid membrane.
Other: Palpation
Using digital Palpation to identify cricothyoid membrane
Other Name: Digital Palpation
Experimental: Ultrasound group

Ultrasongraphy group will consist of 214 patients, who's CTM will be marked using, ultrasonography to identify the CTM.

The Intervention by using the Ultrasound to determine the CTM.

Device: Ultrasongraphy
Using the Ultrasound to determine the location of the CTM.
Other Name: Ultrasound

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with ASA physical status I-III, aged 18 years of age or older, scheduled for neck CT scanning for any indication at the UHN.

Exclusion Criteria:

Patients will be excluded from the study if they are unable to lie flat for the procedure or are unable to maintain a neutral neck position or patients who refuse to participate in the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01725828

Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Principal Investigator: Naveed Siddiqui, MD Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  More Information

Additional Information:

Responsible Party: Dr. Naveed Siddiqui, Assistant Professor, Samuel Lunenfeld Research Institute, Mount Sinai Hospital Identifier: NCT01725828     History of Changes
Other Study ID Numbers: 1-2012
Study First Received: November 9, 2012
Last Updated: November 17, 2014

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
cricothyroid membrane
Difficult Airway Management

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms processed this record on April 27, 2017