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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01725828
First received: November 9, 2012
Last updated: January 7, 2014
Last verified: December 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Defined as palpation of the skin to the placing of the sticker.


Estimated Enrollment: 321
Study Start Date: October 2012
Estimated Study Completion Date: July 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01725828

Contacts
Contact: Naveed Siddiqui, MD 416-586-5270 naveed.siddiqui@uhn.on.ca
Contact: Sherif Boulis, MD,PhD 416-586-5270 sherif.boulis@gmail.com

Locations
Canada, Ontario
UHN Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: University Health Network Research Ethics Board    416-581-7849      
Principal Investigator: Naveed Siddiqui, MD         
Sub-Investigator: SHERIF BOULIS, MD.PhD         
Sub-Investigator: Eric You-Ten, MD         
Sub-Investigator: Eugene Yu, MD         
Sub-Investigator: Devdatta Desai, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Naveed Siddiqui, M.D    4165865270      
Principal Investigator: Naveed Siddiqui, M.D         
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Naveed Siddiqui, MD Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Naveed Siddiqui, Assistant Professor, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01725828     History of Changes
Other Study ID Numbers: 1-2012
Study First Received: November 9, 2012
Last Updated: January 7, 2014
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on October 20, 2014