Accuracy of Ultrasound of Identification of Cricothyroid Membrane.A Randomized Control Trial.
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.
|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.|
- 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.
- 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
- 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.
|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)|
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.
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.
Using the Ultrasound to determine the location of the CTM.
Other Name: Ultrasound
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01725828
|Contact: Naveed Siddiqui, MDfirstname.lastname@example.org|
|Contact: Sherif Boulis, MD,PhDemail@example.com|
|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|
|Principal Investigator:||Naveed Siddiqui, MD||Samuel Lunenfeld Research Institute, Mount Sinai Hospital|