<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/NCT03035786</url>
  </required_header>
  <id_info>
    <org_study_id>1607 Airway Code</org_study_id>
    <nct_id>NCT03035786</nct_id>
  </id_info>
  <brief_title>Airway Code Calls - Survey of Management</brief_title>
  <official_title>Airway Code Calls - Survey of Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tan Tock Seng Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Singapore General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic&#xD;
      help to manage acute airway crises in the hospital (out of theatre, out of Surgical Intensive&#xD;
      Care Unit, SICU).&#xD;
&#xD;
      The anaesthetists are doctors trained in advance airway management. Patients in the hospital&#xD;
      may suffer airway crises e.g. airway obstruction or need for tracheal intubation (insertion&#xD;
      of breathing tube) for various reasons. The on call SICU anaesthetists responds to the airway&#xD;
      code by attending the patient in need and managing the patient at their own discretion.&#xD;
&#xD;
      Airway management will depend on the anaesthetist's knowledge, skills and experience. it will&#xD;
      also depend on the available airway equipment.&#xD;
&#xD;
      We plan to evaluate airway codes for a 24 month period. Parameters include: type of incident;&#xD;
      patient factors (including airway assessment); type of equipment used; anaesthetic drugs&#xD;
      used; airway management chosen by the attending anaesthetist; and, airway complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Airway codes will be managed as standard care. These calls are taken and managed by&#xD;
      anaesthetists on call on SICU. The audit form is filled in by the on call anaesthetist after&#xD;
      the airway code has been managed. This is an audit looking at:&#xD;
&#xD;
      Primary outcome&#xD;
&#xD;
      •Evaluate the type of airway codes that the SICU anaesthetist is called for&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
        -  Patient factors (including airway assessment)&#xD;
&#xD;
        -  Type of equipment used&#xD;
&#xD;
        -  Type of anaesthetic drugs used&#xD;
&#xD;
        -  Airway management chosen by the attending anaesthetist&#xD;
&#xD;
        -  Airway complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Survey the type of airway codes that the SICU anaesthetist is called for</measure>
    <time_frame>One hour post calling of airway code</time_frame>
    <description>Cause of airway codes i.e. respiratory arrest or indication for formal airway management by anaesthetist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survey of types of equipment needed for airway management</measure>
    <time_frame>One hour post calling of airway code</time_frame>
    <description>Type of equipment used include airway bag, bougie, videolaryngoscope</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with predictors of difficult airway</measure>
    <time_frame>One hour post calling of airway code</time_frame>
    <description>Predictors of difficult airway include small mouth opening, short thyromental distance, prominent upper teeth, receding lower jaw, decreased neck movement, previous surgery, previous radiotherapy</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Intubation; Difficult</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All 'airway code' requests for emergency anaesthetic airway support for adults outside&#xD;
        operating theatre and Surgical Intensive Care Unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults outside operating theatre and Surgical Intensive Care Unit requiring emergency&#xD;
             anaesthetic airway support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Wong, MBBS FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick Wong, MBBS FRCA</last_name>
    <phone>+6563214220</phone>
    <email>patrick.wong@singhealth.com.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jinbin Zhang, MBBS MMED</last_name>
    <phone>+6563577772</phone>
    <email>jinbin_zhang@ttsh.com.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Wong, FRCA</last_name>
      <phone>63214220</phone>
      <email>patrick.wong@singhealth.com.sg</email>
    </contact>
    <contact_backup>
      <last_name>Zihui Tan, MMED</last_name>
      <phone>63214220</phone>
      <email>zihui.tan@mohh.com.sg</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinbin Zhang, MMED</last_name>
      <phone>62566011</phone>
      <email>Jinbin_Zhang@ttsh.com.sg</email>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Bowles TM, Freshwater-Turner DA, Janssen DJ, Peden CJ; RTIC Severn Group. Out-of-theatre tracheal intubation: prospective multicentre study of clinical practice and adverse events. Br J Anaesth. 2011 Nov;107(5):687-92. doi: 10.1093/bja/aer251. Epub 2011 Aug 8.</citation>
    <PMID>21828342</PMID>
  </reference>
  <reference>
    <citation>Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415.</citation>
    <PMID>21150574</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03035786
org study id: 1607 Airway Code
nct id: NCT03035786
lead sponsor: 
collaborator: 
has dmc: No
This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic
      help to manage acute airway crises in the hospital (out of theatre, out of Surgical Intensive
      Care Unit, SICU).

      The anaesthetists are doctors trained in advance airway management. Patients in the hospital
      may suffer airway crises e.g. airway obstruction or need for tracheal intubation (insertion
      of breathing tube) for various reasons. The on call SICU anaesthetists responds to the airway
      code by attending the patient in need and managing the patient at their own discretion.

      Airway management will depend on the anaesthetist's knowledge, skills and experience. it will
      also depend on the available airway equipment.

      We plan to evaluate airway codes for a 24 month period. Parameters include: type of incident;
      patient factors (including airway assessment); type of equipment used; anaesthetic drugs
      used; airway management chosen by the attending anaesthetist; and, airway complications.
Airway codes will be managed as standard care. These calls are taken and managed by
      anaesthetists on call on SICU. The audit form is filled in by the on call anaesthetist after
      the airway code has been managed. This is an audit looking at:

      Primary outcome

      •Evaluate the type of airway codes that the SICU anaesthetist is called for

      Secondary outcomes:

        -  Patient factors (including airway assessment)

        -  Type of equipment used

        -  Type of anaesthetic drugs used

        -  Airway management chosen by the attending anaesthetist

        -  Airway complications.
observational model: Cohort
time perspective: Prospective
measure: Survey the type of airway codes that the SICU anaesthetist is called for
time frame: One hour post calling of airway code
description: Cause of airway codes i.e. respiratory arrest or indication for formal airway management by anaesthetist
measure: Survey of types of equipment needed for airway management
time frame: One hour post calling of airway code
description: Type of equipment used include airway bag, bougie, videolaryngoscope
measure: Number of participants with predictors of difficult airway
time frame: One hour post calling of airway code
description: Predictors of difficult airway include small mouth opening, short thyromental distance, prominent upper teeth, receding lower jaw, decreased neck movement, previous surgery, previous radiotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 100 Years
healthy volunteers: No
last name: Patrick Wong, MBBS FRCA
role: Principal Investigator
affiliation: Singapore General Hospital
last name: Patrick Wong, MBBS FRCA
phone: +6563214220
email: patrick.wong@singhealth.com.sg
last name: Jinbin Zhang, MBBS MMED
phone: +6563577772
email: jinbin_zhang@ttsh.com.sg
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Singapore
citation: Bowles TM, Freshwater-Turner DA, Janssen DJ, Peden CJ; RTIC Severn Group. Out-of-theatre tracheal intubation: prospective multicentre study of clinical practice and adverse events. Br J Anaesth. 2011 Nov;107(5):687-92. doi: 10.1093/bja/aer251. Epub 2011 Aug 8.
PMID: 21828342
citation: Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415.
PMID: 21150574
responsible party type: Sponsor
sharing ipd: No