<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/NCT03288519</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03288519</nct_id>
  </id_info>
  <brief_title>Use of Classic LMA During Endovascular Therapy</brief_title>
  <official_title>The Use of the Classic Laryngeal Mask Airway in Patients With Cerebral Aneurysm Undergoing Endovascular Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Antioquia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Antioquia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Earlier treatment and resolution for patients with cerebral aneurysms is now&#xD;
      possible due to earlier diagnosis. This observational study aims to evaluate the&#xD;
      intraoperative cardiovascular parameters in patients with cerebral aneurysms undergoing&#xD;
      endovascular therapy.&#xD;
&#xD;
      Method: This is an observational prospective study. Patients ≥ 18 years old diagnosed with an&#xD;
      unruptured cerebral aneurysm or subarachnoid hemorrhage (SAH) (Hunt &amp; Hess grade I or II)&#xD;
      undergoing endovascular treatment under general anesthesia between April 2015 and February&#xD;
      2017 were included. Non-invasive measurements of hemodynamic variables were collected at six&#xD;
      time points during the procedure (T1 to T6). Statistical analysis was performed by using&#xD;
      central tendency measures for quantitative variables and absolute / relative frequency&#xD;
      measurements for qualitative variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective&#xD;
&#xD;
      • To assess the usefulness of general anesthesia with Laryngeal Mask Airway (LMA)-Classic for&#xD;
      the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis&#xD;
      Data collection Anesthetic protocol was standardized for all patients consisting of an&#xD;
      intravenous induction with fentanyl (1-2 μg/kg), lidocaine (1.5 mg/kg), propofol (2 mg/kg),&#xD;
      and dexamethasone (8 mg) followed by the insertion of the LMA-Classic. Sevoflurane with a&#xD;
      minimal alveolar concentration (MAC) between 0.9 and 1.1%, dipyrone (2 gr IV), and morphine&#xD;
      (0.05 mg/kg IV) were used during maintenance. Tidal volume (VT) and respiratory rate (RR)&#xD;
      were adjusted to 7 ml/Kg and 12-14 per minute respectively. Non-invasive hemodynamic&#xD;
      monitoring included mean arterial pressure (MAP), heart rate (HR), oxygen saturation, and&#xD;
      end-tidal carbon dioxide (ETCO2).&#xD;
&#xD;
      Data was collected within six time points: Time point 1: before induction, Time point 2:&#xD;
      after induction, Time point 3: after LMA-Classic insertion, Time point 4: during the&#xD;
      endovascular procedure, Time point 5: during coiling, and Time point 6: at the end of the&#xD;
      procedure and LMA-Classic removal.&#xD;
&#xD;
      The following demographic and clinical data were collected: age, gender, American Society of&#xD;
      Anesthesiologists Physical Status (ASA-PS), total procedure time, comorbidities, aneurysm&#xD;
      location, and associated clinical manifestations. Adverse events, such as intraoperative&#xD;
      aneurysm rupture or need for endotracheal intubation, will be recorded.&#xD;
&#xD;
      Ethical considerations Approvals were obtained from the ethics committees at Antioquia&#xD;
      University and Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic.&#xD;
      Patients signed an informed consent and confidentiality agreement before participating.&#xD;
&#xD;
      Statistical analysis Data was collected in an excel spreadsheet (Microsoft Excel 2010®), SAS&#xD;
      9.4 (SAS Institute, Cary, N.C.) was used for subsequent analysis. Continuous variables were&#xD;
      summarized as means and standard deviations (SD). Categorical variables were summarized as&#xD;
      frequencies and percentages. Linear mixed models were fit to model continuous clinical&#xD;
      variables over time using contrasts to test differences between time points. P-values less&#xD;
      than 0.05 were considered to be statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hemodynamic changes (changes from baseline in Heart Rate and Mean Arterial Pressure)</measure>
    <time_frame>Outcome measure will be assessed from baseline (defined as time point 1, before induction) until the end of the surgery and laryngeal mask removal (defined as time point 6). Data will be reported within one year after study completion</time_frame>
    <description>• To assess the usefulness of general anesthesia with LMA-Classic for the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis</description>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Cerebral Aneurysm Unruptured</condition>
  <condition>Cerebral Aneurysm</condition>
  <condition>Hemodynamic Instability</condition>
  <condition>Airway Morbidity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        An observational prospective study was undertaken in the Especialidades Médicas&#xD;
        Metropolitanas Sociedad Anónima (EMMSA) Clinic in Bello, Antioquia, Colombia. The&#xD;
        investigators included patients ≥ 18 years old diagnosed with an unruptured cerebral&#xD;
        aneurysm or SAH (Hunt &amp; Hess grade I or II) undergoing endovascular treatment under general&#xD;
        anesthesia between April 2015 and February 2017. The investigators excluded patients&#xD;
        diagnosed with a cerebral aneurysm undergoing craniotomy and clipping and patients with SAH&#xD;
        (Hunt &amp; Hess grade &gt; II).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years old&#xD;
&#xD;
          -  Diagnosed with an unruptured cerebral aneurysm or SAH (Hunt &amp; Hess grade I or II)&#xD;
&#xD;
          -  Planned to undergo endovascular therapy under general anesthesia between April 2015&#xD;
             and February 2017 in the Especialidades Médicas Metropolitanas Sociedad Anónima&#xD;
             (EMMSA) Clinic in Bello, Antioquia, Colombia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with a cerebral aneurysm undergoing craniotomy and clipping and&#xD;
             patients with SAH (Hunt &amp; Hess grade &gt; II).&#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>Francisco J Gomez Oquendo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, University of Antioquia, Medellin, Colombia.</affiliation>
  </overall_official>
  <reference>
    <citation>Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.</citation>
    <PMID>24646873</PMID>
  </reference>
  <reference>
    <citation>Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.</citation>
    <PMID>16943405</PMID>
  </reference>
  <reference>
    <citation>Weir B, Disney L, Karrison T. Sizes of ruptured and unruptured aneurysms in relation to their sites and the ages of patients. J Neurosurg. 2002 Jan;96(1):64-70. doi: 10.3171/jns.2002.96.1.0064.</citation>
    <PMID>11794606</PMID>
  </reference>
  <reference>
    <citation>Chowdhury T, Cappellani RB, Sandu N, Schaller B, Daya J. Perioperative variables contributing to the rupture of intracranial aneurysm: an update. ScientificWorldJournal. 2013 Nov 12;2013:396404. doi: 10.1155/2013/396404.</citation>
    <PMID>24324371</PMID>
  </reference>
  <results_reference>
    <citation>Lee CZ, Young WL. Anesthesia for endovascular neurosurgery and interventional neuroradiology. Anesthesiol Clin. 2012 Jun;30(2):127-47. doi: 10.1016/j.anclin.2012.05.009. Epub 2012 Jul 13.</citation>
    <PMID>22901603</PMID>
  </results_reference>
  <results_reference>
    <citation>Kundra S, Mahendru V, Gupta V, Choudhary AK. Principles of neuroanesthesia in aneurysmal subarachnoid hemorrhage. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):328-37. doi: 10.4103/0970-9185.137261.</citation>
    <PMID>25190938</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cerebral aneurysm</keyword>
  <keyword>Endovascular therapy</keyword>
  <keyword>Classic laryngeal mask airway</keyword>
  <keyword>Hemodynamic changes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>De-identified data will be shared with our colleagues at The Ohio State University for posterior data analysis</ipd_description>
  </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/NCT03288519
org study id: 001
nct id: NCT03288519
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Earlier treatment and resolution for patients with cerebral aneurysms is now
      possible due to earlier diagnosis. This observational study aims to evaluate the
      intraoperative cardiovascular parameters in patients with cerebral aneurysms undergoing
      endovascular therapy.

      Method: This is an observational prospective study. Patients ≥ 18 years old diagnosed with an
      unruptured cerebral aneurysm or subarachnoid hemorrhage (SAH) (Hunt & Hess grade I or II)
      undergoing endovascular treatment under general anesthesia between April 2015 and February
      2017 were included. Non-invasive measurements of hemodynamic variables were collected at six
      time points during the procedure (T1 to T6). Statistical analysis was performed by using
      central tendency measures for quantitative variables and absolute / relative frequency
      measurements for qualitative variables.
Objective

      • To assess the usefulness of general anesthesia with Laryngeal Mask Airway (LMA)-Classic for
      the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis
      Data collection Anesthetic protocol was standardized for all patients consisting of an
      intravenous induction with fentanyl (1-2 μg/kg), lidocaine (1.5 mg/kg), propofol (2 mg/kg),
      and dexamethasone (8 mg) followed by the insertion of the LMA-Classic. Sevoflurane with a
      minimal alveolar concentration (MAC) between 0.9 and 1.1%, dipyrone (2 gr IV), and morphine
      (0.05 mg/kg IV) were used during maintenance. Tidal volume (VT) and respiratory rate (RR)
      were adjusted to 7 ml/Kg and 12-14 per minute respectively. Non-invasive hemodynamic
      monitoring included mean arterial pressure (MAP), heart rate (HR), oxygen saturation, and
      end-tidal carbon dioxide (ETCO2).

      Data was collected within six time points: Time point 1: before induction, Time point 2:
      after induction, Time point 3: after LMA-Classic insertion, Time point 4: during the
      endovascular procedure, Time point 5: during coiling, and Time point 6: at the end of the
      procedure and LMA-Classic removal.

      The following demographic and clinical data were collected: age, gender, American Society of
      Anesthesiologists Physical Status (ASA-PS), total procedure time, comorbidities, aneurysm
      location, and associated clinical manifestations. Adverse events, such as intraoperative
      aneurysm rupture or need for endotracheal intubation, will be recorded.

      Ethical considerations Approvals were obtained from the ethics committees at Antioquia
      University and Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic.
      Patients signed an informed consent and confidentiality agreement before participating.

      Statistical analysis Data was collected in an excel spreadsheet (Microsoft Excel 2010®), SAS
      9.4 (SAS Institute, Cary, N.C.) was used for subsequent analysis. Continuous variables were
      summarized as means and standard deviations (SD). Categorical variables were summarized as
      frequencies and percentages. Linear mixed models were fit to model continuous clinical
      variables over time using contrasts to test differences between time points. P-values less
      than 0.05 were considered to be statistically significant.
observational model: Other
time perspective: Prospective
measure: Hemodynamic changes (changes from baseline in Heart Rate and Mean Arterial Pressure)
time frame: Outcome measure will be assessed from baseline (defined as time point 1, before induction) until the end of the surgery and laryngeal mask removal (defined as time point 6). Data will be reported within one year after study completion
description: • To assess the usefulness of general anesthesia with LMA-Classic for the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francisco J Gomez Oquendo, MD
role: Principal Investigator
affiliation: Department of Anesthesiology, University of Antioquia, Medellin, Colombia.
citation: Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.
PMID: 24646873
citation: Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.
PMID: 16943405
citation: Weir B, Disney L, Karrison T. Sizes of ruptured and unruptured aneurysms in relation to their sites and the ages of patients. J Neurosurg. 2002 Jan;96(1):64-70. doi: 10.3171/jns.2002.96.1.0064.
PMID: 11794606
citation: Chowdhury T, Cappellani RB, Sandu N, Schaller B, Daya J. Perioperative variables contributing to the rupture of intracranial aneurysm: an update. ScientificWorldJournal. 2013 Nov 12;2013:396404. doi: 10.1155/2013/396404.
PMID: 24324371
citation: Lee CZ, Young WL. Anesthesia for endovascular neurosurgery and interventional neuroradiology. Anesthesiol Clin. 2012 Jun;30(2):127-47. doi: 10.1016/j.anclin.2012.05.009. Epub 2012 Jul 13.
PMID: 22901603
citation: Kundra S, Mahendru V, Gupta V, Choudhary AK. Principles of neuroanesthesia in aneurysmal subarachnoid hemorrhage. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):328-37. doi: 10.4103/0970-9185.137261.
PMID: 25190938
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
sharing ipd: No
ipd description: De-identified data will be shared with our colleagues at The Ohio State University for posterior data analysis