<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/NCT01682707</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE-0021.0.185.000-09</org_study_id>
    <nct_id>NCT01682707</nct_id>
  </id_info>
  <brief_title>Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients</brief_title>
  <official_title>Randomized Clinical Trials to Compare the Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients Undergoing CABG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Juiz de Fora</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Juiz de Fora</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Opioids provide greater patient comfort during intubation, but are not able to abolish&#xD;
      completely the release adrenergic hormones during the laryngoscopy, which may cause&#xD;
      undesirable hemodynamic changes.&#xD;
&#xD;
      In this study the investigators selected two techniques commonly used for intubation,&#xD;
      laryngoscopy and track light, so the investigators can verify which intubation techniques&#xD;
      provides less hemodynamic changes in coronary patients under standard anesthesia induction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">March 2010</completion_date>
  <primary_completion_date type="Actual">March 2010</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hemodynamic response</measure>
    <time_frame>patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation</time_frame>
    <description>tracheal intubation with track light release less adrenergic hormones than laryngoscopy intubation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Coronary Disease Undergoing CABG</condition>
  <arm_group>
    <arm_group_label>Laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laryngoscopy Track Light teaqueal intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Track Light</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laryngoscopy</intervention_name>
    <description>tracheal intubation with two different techniques, track light and laryngoscopy.</description>
    <arm_group_label>Laryngoscopy</arm_group_label>
    <other_name>rigidy laryngoscopy,</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>track light</intervention_name>
    <arm_group_label>Track Light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  coronary disease ASA 2 e 3 using beta-blockers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery arrythmia other antiarrythmic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcello F Salgado filho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Juiz de Fora</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Cardiology / Ministry of Health</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>22240-005</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.sba.com.br</url>
    <description>Sociedade brasileira de Anestesiologia</description>
  </link>
  <link>
    <url>http://www.ufjf.edu.br</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.inc.saude.gov.br</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.scahq.org</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://bja.oxfordjournals.org</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Nishiyama T, Misawa K, Yokoyama T, Hanaoka K. Effects of combining midazolam and barbiturate on the response to tracheal intubation: changes in autonomic nervous system. J Clin Anesth. 2002 Aug;14(5):344-8. doi: 10.1016/s0952-8180(02)00370-7.</citation>
    <PMID>12208438</PMID>
  </reference>
  <results_reference>
    <citation>Nora FS, Klipel R, Ayala G, Oliveira Filho GR. [Remifentanil: does the infusion regimen make a difference in the prevention of hemodynamic responses to tracheal intubation?]. Rev Bras Anestesiol. 2007 Jun;57(3):247-60. doi: 10.1590/s0034-70942007000300003. Portuguese.</citation>
    <PMID>19466360</PMID>
  </results_reference>
  <results_reference>
    <citation>Almeida MC, Martins RS, Martins AL. [Tracheal intubation conditions at 60 seconds in children, adults and elderly patients.]. Rev Bras Anestesiol. 2004 Apr;54(2):204-11. doi: 10.1590/s0034-70942004000200007. Portuguese.</citation>
    <PMID>19471727</PMID>
  </results_reference>
  <verification_date>April 2012</verification_date>
  <study_first_submitted>April 1, 2010</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Juiz de Fora</investigator_affiliation>
    <investigator_full_name>Marcello F Salgado Filho, MD</investigator_full_name>
    <investigator_title>Master</investigator_title>
  </responsible_party>
  <keyword>intubation</keyword>
  <keyword>coronary disease</keyword>
  <keyword>hemodynamic response</keyword>
  <keyword>anesthesia with tracheal intubation</keyword>
  <keyword>assessment of hemodynamic response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</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/NCT01682707
org study id: CAAE-0021.0.185.000-09
nct id: NCT01682707
lead sponsor: 
has dmc: Yes
Opioids provide greater patient comfort during intubation, but are not able to abolish
      completely the release adrenergic hormones during the laryngoscopy, which may cause
      undesirable hemodynamic changes.

      In this study the investigators selected two techniques commonly used for intubation,
      laryngoscopy and track light, so the investigators can verify which intubation techniques
      provides less hemodynamic changes in coronary patients under standard anesthesia induction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: hemodynamic response
time frame: patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation
description: tracheal intubation with track light release less adrenergic hormones than laryngoscopy intubation
arm group label: Laryngoscopy
arm group type: Active Comparator
description: Laryngoscopy Track Light teaqueal intubation
arm group label: Track Light
arm group type: Active Comparator
intervention type: Procedure
intervention name: laryngoscopy
description: tracheal intubation with two different techniques, track light and laryngoscopy.
arm group label: Laryngoscopy
other name: rigidy laryngoscopy,
intervention type: Procedure
intervention name: track light
arm group label: Track Light
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Marcello F Salgado filho, MD
role: Principal Investigator
affiliation: Federal University of Juiz de Fora
facility: 
country: Brazil
url: http://www.sba.com.br
description: Sociedade brasileira de Anestesiologia
url: http://www.ufjf.edu.br
description: Related Info
url: http://www.inc.saude.gov.br
description: Related Info
url: http://www.scahq.org
description: Related Info
url: http://bja.oxfordjournals.org
description: Related Info
citation: Nishiyama T, Misawa K, Yokoyama T, Hanaoka K. Effects of combining midazolam and barbiturate on the response to tracheal intubation: changes in autonomic nervous system. J Clin Anesth. 2002 Aug;14(5):344-8. doi: 10.1016/s0952-8180(02)00370-7.
PMID: 12208438
citation: Nora FS, Klipel R, Ayala G, Oliveira Filho GR. [Remifentanil: does the infusion regimen make a difference in the prevention of hemodynamic responses to tracheal intubation?]. Rev Bras Anestesiol. 2007 Jun;57(3):247-60. doi: 10.1590/s0034-70942007000300003. Portuguese.
PMID: 19466360
citation: Almeida MC, Martins RS, Martins AL. [Tracheal intubation conditions at 60 seconds in children, adults and elderly patients.]. Rev Bras Anestesiol. 2004 Apr;54(2):204-11. doi: 10.1590/s0034-70942004000200007. Portuguese.
PMID: 19471727
responsible party type: Principal Investigator
investigator affiliation: Federal University of Juiz de Fora
investigator full name: Marcello F Salgado Filho, MD
investigator title: Master
mesh term: Coronary Disease
mesh term: Coronary Artery Disease