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Accuracy of Ultrasound in Identification of Cricothyroid Membrane: A Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT01725828
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : January 11, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 cricothyrotomy (CTY).

CTY is a life 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 the identification of CTM would be 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 or disease Intervention/treatment
Difficult Breathing Device: Ultrasound Other: External Palpation

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ultrasound is Superior to Conventional Palpation Method in Identification of the Cricothyroid Membrane in Subjects With Poorly Defined Neck Landmarks: A Randomized Clinical Trial
Study Start Date : October 2012
Primary Completion Date : June 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: External Palpation group
External Palpation group will consist of 109 patients, who's CTM will be marked using traditional palpation technique of identifying the Cricothyroid membrane.
Other: External Palpation
Using External Palpation to identify cricothyoid membrane
Other Name: Digital Palpation
Experimental: Ultrasound group

Ultrasound group will consist of 114 patients, who's CTM will be marked using, ultrasonography to identify the CTM.

The Intervention by using the Ultrasound to determine the CTM.

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

Outcome Measures

Primary Outcome Measures :
  1. accuracy in identification of the Cricothyroid Membrane [ Time Frame: Less than 1 min ]
    which was defined as the distance (mm) from the CT point to the US point or EP point as measured by a digital ruler

Secondary Outcome Measures :
  1. the proportion of accurate attempts [ Time Frame: about 5 min ]
    defined as a distance ≤ 5mm from the CT point to the Ultrasound Point or External Palpation point.

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

ASA physical status I-III patients aged ≥ 18 with neck pathology who were scheduled for a neck CT scan at University Health Network. All patients recruited in the study had neck pathologies including previous neck surgery, irradiation and/or neck mass.

Exclusion Criteria:

patients who were unable to lie flat, unable to maintain a neutral neck position and those who refused to participate in the study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, MSc Samuel Lunenfeld Research Institute, Mount Sinai Hospital
More Information

Additional Information:

Responsible Party: Dr. Naveed Siddiqui, Associate Professor, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01725828     History of Changes
Other Study ID Numbers: 1-2012
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Cricothyroid membrane
Neck landmarks
External palpation

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms