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

Primary Purpose

Difficult Breathing

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound
External Palpation
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Difficult Breathing focused on measuring Cricothyroid membrane, Ultrasound, Neck landmarks, External palpation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UHN
  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

External Palpation group

Ultrasound group

Arm Description

External Palpation group will consist of 109 patients, who's CTM will be marked using traditional palpation technique of identifying the Cricothyroid membrane.

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.

Outcomes

Primary Outcome Measures

accuracy in identification of the Cricothyroid Membrane
accuracy in identification of the CM which was measured by a digital ruler in millimeter from the CT-point to the US-point or EP-point. We defined success as the proportion of accurate attempts within 5 mm distance from the CT-point to the US-point or EP-point.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2012
Last Updated
April 17, 2018
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01725828
Brief Title
Accuracy of Ultrasound in Identification of Cricothyroid Membrane: A Randomized Clinical Trial
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 Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
Inability to secure the airway remains the most frequent cause of anesthesia-related mishaps.Difficult airway management continues to be the major challenge in anesthesia as it is responsible for a third of anesthesia-related claims and is the single largest class of closed claim injury suits. Difficulties in tracheal intubation is the most frequent cause of anesthesia-related morbidity and mortality. Repeated attempts of tracheal intubations can result in serious soft tissue injury and rapidly deteriorate into a life threatening "cannot intubate-cannot ventilate" (CICV) crisis. The guidelines suggested by the American Society of Anesthesiologists and the Difficult Airway Society for managing the unanticipated difficult airway recommend the performance of a cricothyrotomy(CTY) as the next step for a CICV scenario. Cricothyrotomy is an infrequently performed life saving procedure when facing a difficult CICV airway.Previous studies quote, the incidence of the CICV scenario to be in the range of 0.01-2 per 10,000 cases. It is therefore imperative that anesthesiologists have the necessary knowledge and skills in successfully managing this life-threatening airway crisis. However, several studies demonstrated that many practicing anesthesiologists and anesthesia trainees (residents/fellows) are uncomfortable with the management of a CICV situation because it is such a rare event. A recent Canadian survey shows that only a quarter of the residents and 40% of practicing anesthesiologists were comfortable with performing a cricothyrotomy. Similar findings were reported in a German national survey of academic teaching hospitals where difficult airway situations, particularly a CICV crisis, were poorly managed and were postulated to have contributed to adverse patient outcomes.Complications of emergency CTY by physicians are common, with rates ranging from 9% to 40%.These complications include failure to cannulate the trachea, false airway passage, severe bleeding, posterior tracheal wall injuries, pneumothorax and esophageal laceration. All of these major complications may be related to improper identification of anatomical landmarks used to identify the correct position of cricothyroid membrane (CTM). The current method of CTY relies solely on digital palpation of these landmarks to accurately identify the CTM. Several studies have identified independent predictors for patients with difficult airway. These include characteristics such as high body mass index, presence of beard, short bull neck, distorted neck anatomy either due to congenital or acquired pathology such as goiters or radiation to the neck. These are the same factors which may lead to improper identification of neck landmarks for the CTY. The outcome and accuracy of CTY may be improved with better preparedness and pre-procedural identification of the neck landmarks for CTY before deciding the method of anesthetic. This is especially true in patients with anatomical features of difficult airway, who may be the ones more likely to have a difficult airway or require an emergency CT. In this patient population, incorrect localization of the CTM may lead to significant airway morbidity or failure to quickly establish an airway. The role of ultrasound in airway management: Bedside ultrasound is increasingly being used to assist anesthesiologists in performing various procedures.The use of ultrasonography (US) has been shown to significantly reduce complications and improve outcomes. Diagnostic application of US for upper airway anatomy and its role for the performance of CTY and bedside tracheostomy has been previously described. However, little is known on the reliability and validity of the US when compared to the gold standard CT scan in identifying the CTM. The methods used to identify CTM are based on identification of anatomical landmarks and digital palpation. This may be difficult in patients with poorly defined anatomy, the very same population in which the likelihood of a difficult intubation/emergency surgical airway are higher. The trachea and paratracheal soft tissues of the neck can be examined at the highest resolution with US probes of high frequency due to their superficial position. The anterior tracheal wall, thyroid and cricoid cartilages, tracheal rings, and pre-tracheal tissue may all be well visualized , which allows the clinician to select the optimal space for CTY tube placement. The use of US for assisting with airway management in anesthesia and in the intensive care unit is directly related to the availability of low-cost and portable US capabilities. Clinicians initially described US-guided central venous catheterization, followed by US-guided regional anesthesia techniques. Recently, a few studies examined the role of US for emergency airway procedures. Nichollas et al developed a standardized US technique to identify the CTM. The findings in this study suggest that the CTM and relevant structures can be quickly identified by emergency physicians using US technique. However this study was limited to patients with normal airway and mainly focused to the standardization of technique. it did not validate the technique against a gold standard. In another study Muhammad et al, reported four cases in which ultrasound was successfully used to perform percutaneous tracheostomy in the ICU. Cricothyroid membrane can easily be located on CT scan. In summary, inability to secure the airway remains the most frequent cause of anesthesia-related morbidity and mortality. CTY is highly dependent on proper identification of anatomical land-marks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult Breathing
Keywords
Cricothyroid membrane, Ultrasound, Neck landmarks, External palpation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External Palpation group
Arm Type
Experimental
Arm Description
External Palpation group will consist of 109 patients, who's CTM will be marked using traditional palpation technique of identifying the Cricothyroid membrane.
Arm Title
Ultrasound group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Other Intervention Name(s)
Ultrasonography
Intervention Description
Using the Ultrasound to determine the location of the CTM.
Intervention Type
Other
Intervention Name(s)
External Palpation
Other Intervention Name(s)
Digital Palpation
Intervention Description
Using External Palpation to identify cricothyoid membrane
Primary Outcome Measure Information:
Title
accuracy in identification of the Cricothyroid Membrane
Description
accuracy in identification of the CM which was measured by a digital ruler in millimeter from the CT-point to the US-point or EP-point. We defined success as the proportion of accurate attempts within 5 mm distance from the CT-point to the US-point or EP-point.
Time Frame
Less than 1 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveed Siddiqui, MD, MSc
Organizational Affiliation
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
2339799
Citation
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Citation
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Links:
URL
http://emedicine.medscape.com/article/1830008-overview
Description
Cricothyroidotomy is indicated upon failure to obtain an airway
URL
http://www.youtube.com/watch?v=z0egxtce0LQ
Description
Ultrasound Assisted Cricothyrotomy
URL
http://clinicaltrials.gov/ct2/show/NCT01475487
Description
Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks

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

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