<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01725828</url>
  </required_header>
  <id_info>
    <org_study_id>1-2012</org_study_id>
    <nct_id>NCT01725828</nct_id>
  </id_info>
  <brief_title>Accuracy of Ultrasound in Identification of Cricothyroid Membrane: A Randomized Clinical Trial</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Routine surgery requires artificial breathing through the placement of a plastic tube into&#xD;
      the patient's windpipe via mouth or nose. This tube serves as the source of providing oxygen&#xD;
      to the patients during surgery. Difficulties during insertion of this tube may lead to&#xD;
      serious complications and during this life-threatening crisis the only way to provide oxygen&#xD;
      to the patient is by the help of a procedure called cricothyrotomy (CTY).&#xD;
&#xD;
      CTY is a life saving procedure that involves an incision on the patient neck at a very&#xD;
      precise location called Cricothyroid Membrane (CTM). The current method of identifying this&#xD;
      location is by palpation of neck cartilages by the operator. The incorrect identification of&#xD;
      the CTM could lead to many complications. In certain patients such as obese or distorted neck&#xD;
      features the identification of CTM would be difficult. Ultrasound (US) has improved the&#xD;
      success rate of many anesthesia procedures .Its use has been described for identification of&#xD;
      neck structures; however, this technique of localization has not been validated against the&#xD;
      gold standard which is the use of CT scan. The purpose of our study is to determine the&#xD;
      precision of identifying the CTM using the US versus the conventional finger palpation when&#xD;
      compared to the gold standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inability to secure the airway remains the most frequent cause of anesthesia-related&#xD;
      mishaps.Difficult airway management continues to be the major challenge in anesthesia as it&#xD;
      is responsible for a third of anesthesia-related claims and is the single largest class of&#xD;
      closed claim injury suits. Difficulties in tracheal intubation is the most frequent cause of&#xD;
      anesthesia-related morbidity and mortality.&#xD;
&#xD;
      Repeated attempts of tracheal intubations can result in serious soft tissue injury and&#xD;
      rapidly deteriorate into a life threatening &quot;cannot intubate-cannot ventilate&quot; (CICV) crisis.&#xD;
      The guidelines suggested by the American Society of Anesthesiologists and the Difficult&#xD;
      Airway Society for managing the unanticipated difficult airway recommend the performance of a&#xD;
      cricothyrotomy(CTY) as the next step for a CICV scenario.&#xD;
&#xD;
      Cricothyrotomy is an infrequently performed life saving procedure when facing a difficult&#xD;
      CICV airway.Previous studies quote, the incidence of the CICV scenario to be in the range of&#xD;
      0.01-2 per 10,000 cases. It is therefore imperative that anesthesiologists have the necessary&#xD;
      knowledge and skills in successfully managing this life-threatening airway crisis. However,&#xD;
      several studies demonstrated that many practicing anesthesiologists and anesthesia trainees&#xD;
      (residents/fellows) are uncomfortable with the management of a CICV situation because it is&#xD;
      such a rare event. A recent Canadian survey shows that only a quarter of the residents and&#xD;
      40% of practicing anesthesiologists were comfortable with performing a cricothyrotomy.&#xD;
      Similar findings were reported in a German national survey of academic teaching hospitals&#xD;
      where difficult airway situations, particularly a CICV crisis, were poorly managed and were&#xD;
      postulated to have contributed to adverse patient outcomes.Complications of emergency CTY by&#xD;
      physicians are common, with rates ranging from 9% to 40%.These complications include failure&#xD;
      to cannulate the trachea, false airway passage, severe bleeding, posterior tracheal wall&#xD;
      injuries, pneumothorax and esophageal laceration. All of these major complications may be&#xD;
      related to improper identification of anatomical landmarks used to identify the correct&#xD;
      position of cricothyroid membrane (CTM). The current method of CTY relies solely on digital&#xD;
      palpation of these landmarks to accurately identify the CTM.&#xD;
&#xD;
      Several studies have identified independent predictors for patients with difficult airway.&#xD;
      These include characteristics such as high body mass index, presence of beard, short bull&#xD;
      neck, distorted neck anatomy either due to congenital or acquired pathology such as goiters&#xD;
      or radiation to the neck. These are the same factors which may lead to improper&#xD;
      identification of neck landmarks for the CTY.&#xD;
&#xD;
      The outcome and accuracy of CTY may be improved with better preparedness and pre-procedural&#xD;
      identification of the neck landmarks for CTY before deciding the method of anesthetic. This&#xD;
      is especially true in patients with anatomical features of difficult airway, who may be the&#xD;
      ones more likely to have a difficult airway or require an emergency CT. In this patient&#xD;
      population, incorrect localization of the CTM may lead to significant airway morbidity or&#xD;
      failure to quickly establish an airway.&#xD;
&#xD;
      The role of ultrasound in airway management:&#xD;
&#xD;
      Bedside ultrasound is increasingly being used to assist anesthesiologists in performing&#xD;
      various procedures.The use of ultrasonography (US) has been shown to significantly reduce&#xD;
      complications and improve outcomes. Diagnostic application of US for upper airway anatomy and&#xD;
      its role for the performance of CTY and bedside tracheostomy has been previously described.&#xD;
      However, little is known on the reliability and validity of the US when compared to the gold&#xD;
      standard CT scan in identifying the CTM.&#xD;
&#xD;
      The methods used to identify CTM are based on identification of anatomical landmarks and&#xD;
      digital palpation. This may be difficult in patients with poorly defined anatomy, the very&#xD;
      same population in which the likelihood of a difficult intubation/emergency surgical airway&#xD;
      are higher.&#xD;
&#xD;
      The trachea and paratracheal soft tissues of the neck can be examined at the highest&#xD;
      resolution with US probes of high frequency due to their superﬁcial position. The anterior&#xD;
      tracheal wall, thyroid and cricoid cartilages, tracheal rings, and pre-tracheal tissue may&#xD;
      all be well visualized , which allows the clinician to select the optimal space for CTY tube&#xD;
      placement. The use of US for assisting with airway management in anesthesia and in the&#xD;
      intensive care unit is directly related to the availability of low-cost and portable US&#xD;
      capabilities. Clinicians initially described US-guided central venous catheterization,&#xD;
      followed by US-guided regional anesthesia techniques. Recently, a few studies examined the&#xD;
      role of US for emergency airway procedures. Nichollas et al developed a standardized US&#xD;
      technique to identify the CTM. The findings in this study suggest that the CTM and relevant&#xD;
      structures can be quickly identified by emergency physicians using US technique. However this&#xD;
      study was limited to patients with normal airway and mainly focused to the standardization of&#xD;
      technique. it did not validate the technique against a gold standard. In another study&#xD;
      Muhammad et al, reported four cases in which ultrasound was successfully used to perform&#xD;
      percutaneous tracheostomy in the ICU. Cricothyroid membrane can easily be located on CT scan.&#xD;
&#xD;
      In summary, inability to secure the airway remains the most frequent cause of&#xD;
      anesthesia-related morbidity and mortality. CTY is highly dependent on proper identification&#xD;
      of anatomical land-marks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>accuracy in identification of the Cricothyroid Membrane</measure>
    <time_frame>Less than 1 min</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">223</enrollment>
  <condition>Difficult Breathing</condition>
  <arm_group>
    <arm_group_label>External Palpation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>External Palpation group will consist of 109 patients, who's CTM will be marked using traditional palpation technique of identifying the Cricothyroid membrane.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound group will consist of 114 patients, who's CTM will be marked using, ultrasonography to identify the CTM.&#xD;
The Intervention by using the Ultrasound to determine the CTM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Using the Ultrasound to determine the location of the CTM.</description>
    <arm_group_label>Ultrasound group</arm_group_label>
    <other_name>Ultrasonography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>External Palpation</intervention_name>
    <description>Using External Palpation to identify cricothyoid membrane</description>
    <arm_group_label>External Palpation group</arm_group_label>
    <other_name>Digital Palpation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ASA physical status I-III patients aged ≥ 18 with neck pathology who were scheduled for a&#xD;
        neck CT scan at University Health Network. All patients recruited in the study had neck&#xD;
        pathologies including previous neck surgery, irradiation and/or neck mass.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        patients who were unable to lie flat, unable to maintain a neutral neck position and those&#xD;
        who refused to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naveed Siddiqui, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UHN</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://emedicine.medscape.com/article/1830008-overview</url>
    <description>Cricothyroidotomy is indicated upon failure to obtain an airway</description>
  </link>
  <link>
    <url>http://www.youtube.com/watch?v=z0egxtce0LQ</url>
    <description>Ultrasound Assisted Cricothyrotomy</description>
  </link>
  <link>
    <url>http://clinicaltrials.gov/ct2/show/NCT01475487</url>
    <description>Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks</description>
  </link>
  <results_reference>
    <citation>Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.</citation>
    <PMID>2339799</PMID>
  </results_reference>
  <results_reference>
    <citation>Domino KB, Posner KL, Caplan RA, Cheney FW. Airway injury during anesthesia: a closed claims analysis. Anesthesiology. 1999 Dec;91(6):1703-11. doi: 10.1097/00000542-199912000-00023.</citation>
    <PMID>10598613</PMID>
  </results_reference>
  <results_reference>
    <citation>American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2003 May;98(5):1269-77. doi: 10.1097/00000542-200305000-00032. No abstract available. Erratum In: Anesthesiology. 2004 Aug;101(2):565.</citation>
    <PMID>12717151</PMID>
  </results_reference>
  <results_reference>
    <citation>Segal R. A response to 'Difficult Airway Society guidelines for management of the unanticipated difficult intubation', Henderson JJ, Popat MT, Latto IP and Pearce AC, Anaesthesia 2004; 59: 675-94. Anaesthesia. 2004 Nov;59(11):1150-1. doi: 10.1111/j.1365-2044.2004.04005.x. No abstract available.</citation>
    <PMID>15479346</PMID>
  </results_reference>
  <results_reference>
    <citation>Mori M, Fujimoto J, Iwasaka H, Noguchi T. Emergency percutaneous dilatational cricothyroidotomy after failed intubation. Anaesth Intensive Care. 2002 Feb;30(1):101-2. No abstract available.</citation>
    <PMID>11939430</PMID>
  </results_reference>
  <results_reference>
    <citation>Griggs WM, Myburgh JA, Worthley LI. Urgent airway access--an indication for percutaneous tracheostomy? Anaesth Intensive Care. 1991 Nov;19(4):586-7. doi: 10.1177/0310057X9101900421. No abstract available.</citation>
    <PMID>1750647</PMID>
  </results_reference>
  <results_reference>
    <citation>Goldmann K, Braun U. Airway management practices at German university and university-affiliated teaching hospitals--equipment, techniques and training: results of a nationwide survey. Acta Anaesthesiol Scand. 2006 Mar;50(3):298-305. doi: 10.1111/j.1399-6576.2006.00853.x.</citation>
    <PMID>16480462</PMID>
  </results_reference>
  <results_reference>
    <citation>Wong DT, Lai K, Chung FF, Ho RY. Cannot intubate-cannot ventilate and difficult intubation strategies: results of a Canadian national survey. Anesth Analg. 2005 May;100(5):1439-1446. doi: 10.1213/01.ANE.0000148695.37190.34.</citation>
    <PMID>15845702</PMID>
  </results_reference>
  <results_reference>
    <citation>Bair AE, Panacek EA, Wisner DH, Bales R, Sakles JC. Cricothyrotomy: a 5-year experience at one institution. J Emerg Med. 2003 Feb;24(2):151-6. doi: 10.1016/s0736-4679(02)00715-1.</citation>
    <PMID>12609644</PMID>
  </results_reference>
  <results_reference>
    <citation>McGill J, Clinton JE, Ruiz E. Cricothyrotomy in the emergency department. Ann Emerg Med. 1982 Jul;11(7):361-4. doi: 10.1016/s0196-0644(82)80362-4.</citation>
    <PMID>7091796</PMID>
  </results_reference>
  <results_reference>
    <citation>Hsiao J, Pacheco-Fowler V. Videos in clinical medicine. Cricothyroidotomy. N Engl J Med. 2008 May 29;358(22):e25. doi: 10.1056/NEJMvcm0706755. No abstract available.</citation>
    <PMID>18509116</PMID>
  </results_reference>
  <results_reference>
    <citation>Kumar A, Chuan A. Ultrasound guided vascular access: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):299-311. doi: 10.1016/j.bpa.2009.02.006.</citation>
    <PMID>19862889</PMID>
  </results_reference>
  <results_reference>
    <citation>Levin PD, Sheinin O, Gozal Y. Use of ultrasound guidance in the insertion of radial artery catheters. Crit Care Med. 2003 Feb;31(2):481-4. doi: 10.1097/01.CCM.0000050452.17304.2F.</citation>
    <PMID>12576955</PMID>
  </results_reference>
  <results_reference>
    <citation>Warman P, Nicholls B. Ultrasound-guided nerve blocks: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):313-26. doi: 10.1016/j.bpa.2009.02.004.</citation>
    <PMID>19862890</PMID>
  </results_reference>
  <results_reference>
    <citation>Erkan M, Tolu I, Aslan T, Guney E. Ultrasonography in laryngeal cancers. J Laryngol Otol. 1993 Jan;107(1):65-8. doi: 10.1017/s0022215100122182.</citation>
    <PMID>8445322</PMID>
  </results_reference>
  <results_reference>
    <citation>Sustic A, Zupan Z, Antoncic I. Ultrasound-guided percutaneous dilatational tracheostomy with laryngeal mask airway control in a morbidly obese patient. J Clin Anesth. 2004 Mar;16(2):121-3. doi: 10.1016/j.jclinane.2003.04.005.</citation>
    <PMID>15110374</PMID>
  </results_reference>
  <results_reference>
    <citation>Muhammad JK, Patton DW, Evans RM, Major E. Percutaneous dilatational tracheostomy under ultrasound guidance. Br J Oral Maxillofac Surg. 1999 Aug;37(4):309-11. doi: 10.1054/bjom.1999.0072.</citation>
    <PMID>10475654</PMID>
  </results_reference>
  <results_reference>
    <citation>Nicholls SE, Sweeney TW, Ferre RM, Strout TD. Bedside sonography by emergency physicians for the rapid identification of landmarks relevant to cricothyrotomy. Am J Emerg Med. 2008 Oct;26(8):852-6. doi: 10.1016/j.ajem.2007.11.022.</citation>
    <PMID>18926340</PMID>
  </results_reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Naveed Siddiqui</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cricothyroid membrane</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Neck landmarks</keyword>
  <keyword>External palpation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01725828
org study id: 1-2012
nct id: NCT01725828
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: accuracy in identification of the Cricothyroid Membrane
time frame: Less than 1 min
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.
arm group label: External Palpation group
arm group type: Experimental
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 group label: Ultrasound group
arm group type: Experimental
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: Ultrasound
description: Using the Ultrasound to determine the location of the CTM.
arm group label: Ultrasound group
other name: Ultrasonography
intervention type: Other
intervention name: External Palpation
description: Using External Palpation to identify cricothyoid membrane
arm group label: External Palpation group
other name: Digital Palpation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naveed Siddiqui, MD, MSc
role: Principal Investigator
affiliation: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
facility: 
facility: 
country: Canada
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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PMID: 18926340
responsible party type: Principal Investigator
investigator affiliation: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
investigator full name: Dr. Naveed Siddiqui
investigator title: Associate Professor
mesh term: Dyspnea