<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/NCT02241798</url>
  </required_header>
  <id_info>
    <org_study_id>S13-00435</org_study_id>
    <nct_id>NCT02241798</nct_id>
  </id_info>
  <brief_title>Pre-oxygenation and Measures of Gas Exchanges During Seizures in the Epilepsy Monitoring Unit</brief_title>
  <official_title>Effects of Pre-oxygenation on Indicators of Gas Exchange and Autonomic Function During Seizures in the Epilepsy Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon&#xD;
      dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU).&#xD;
      The investigators hypothesize that providing oxygen prior to seizures will help eliminate the&#xD;
      drops in changes seen during seizures, such as the drop in oxygen saturation and increase in&#xD;
      carbon dioxide levels.&#xD;
&#xD;
      Research will be done on patients that are admitted to the EMU specifically to have seizures&#xD;
      occur and to be recorded on video electroencephalography (vEEG), and the only research&#xD;
      intervention will be the use of oxygen prior to some of the seizures.&#xD;
&#xD;
      The importance of this research relates to the phenomenon of sudden unexplained death in&#xD;
      epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found&#xD;
      dead by their families in the morning, without a clear cause for death. The risk of SUDEP is&#xD;
      as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple&#xD;
      mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation&#xD;
      during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to&#xD;
      decrease significantly in 25-50% of patients during or shortly after a seizure while being&#xD;
      monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger&#xD;
      a cascade of events from which the body may not be able to recover, leading to SUDEP. In&#xD;
      animal models, providing oxygen prior to seizures occurring has been shown to eliminate&#xD;
      oxygen desaturation, but more importantly eliminate mortality in animals prone to death due&#xD;
      to seizures.&#xD;
&#xD;
      Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it&#xD;
      reduces the risk of oxygen desaturation during the apneic period of the procedure. On room&#xD;
      air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes&#xD;
      following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to&#xD;
      oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs&#xD;
      from which transfer to the bloodstream can continue despite the lack of ventilation. The&#xD;
      apneic episode during seizures should benefit from the same principle.&#xD;
&#xD;
      The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better&#xD;
      characterize seizures, to identify the main seizure focus. In addition to standard EEG with&#xD;
      electrodes on the scalp, some patients require invasive localization of the epileptic focus&#xD;
      by surgically placing electrodes within the skull (often referred to as GRID patients) on or&#xD;
      within the brain, with the goal of being able to resect the area that is causing seizures. To&#xD;
      identify where seizure originate electrically, it requires that seizures occur during the&#xD;
      vEEG procedure. To provoke seizures, medications are typically lowered, and both partial&#xD;
      seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will&#xD;
      occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex&#xD;
      partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use&#xD;
      oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the investigators&#xD;
      also have the capability for both for clinical usage.&#xD;
&#xD;
      Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs&#xD;
      following seizures as part of the post-ictal nursing care, though there is no outcome data to&#xD;
      support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of&#xD;
      oxygen desaturations clinically, as seen in animal models, and this is the goal of this&#xD;
      research project.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator is leaving the institution and has terminated the study.&#xD;
  </why_stopped>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">August 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen desaturation below 92% following GTCs</measure>
    <time_frame>during and up to 6 minutes following the seizure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Desaturations below 80% following GTCs</measure>
    <time_frame>during and up to 6 minutes following seizures</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Pre-oxygenation first</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>st, 3rd, 5th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated&#xD;
nd, 4th, 6th, etc seizure: Standard practice (O2 only in post-ictal period).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard practice first</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>st, 3rd, 5th, etc seizure: Standard practice (O2 only in post-ictal period).&#xD;
nd, 4th, 6th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>oxygen</intervention_name>
    <description>O2 by nasal prongs</description>
    <arm_group_label>Pre-oxygenation first</arm_group_label>
    <arm_group_label>Standard practice first</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged 18-70 yo admitted for monitoring and capturing seizures at the EMU with&#xD;
             scalp electrodes and for seizure localization with implantation of intracranial&#xD;
             electrodes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who are considered healthy enough to provoke seizure activity will have few&#xD;
             medical illnesses severe enough to be of concern with respect to continuous oxygen&#xD;
             delivery. However, patients will be screened for moderate to severe chronic&#xD;
             obstructive pulmonary disease and excluded, as their minute ventilation may decrease&#xD;
             and CO2 levels increased with continuous oxygen supplementation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 10, 2017</last_update_submitted>
  <last_update_submitted_qc>March 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epilepsy</keyword>
  <keyword>oxygen saturation</keyword>
  <keyword>transcutaneous carbon dioxide</keyword>
  <keyword>sudep</keyword>
  <keyword>pre-oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</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/NCT02241798
org study id: S13-00435
nct id: NCT02241798
lead sponsor: 
has dmc: No
The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon
      dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU).
      The investigators hypothesize that providing oxygen prior to seizures will help eliminate the
      drops in changes seen during seizures, such as the drop in oxygen saturation and increase in
      carbon dioxide levels.

      Research will be done on patients that are admitted to the EMU specifically to have seizures
      occur and to be recorded on video electroencephalography (vEEG), and the only research
      intervention will be the use of oxygen prior to some of the seizures.

      The importance of this research relates to the phenomenon of sudden unexplained death in
      epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found
      dead by their families in the morning, without a clear cause for death. The risk of SUDEP is
      as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple
      mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation
      during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to
      decrease significantly in 25-50% of patients during or shortly after a seizure while being
      monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger
      a cascade of events from which the body may not be able to recover, leading to SUDEP. In
      animal models, providing oxygen prior to seizures occurring has been shown to eliminate
      oxygen desaturation, but more importantly eliminate mortality in animals prone to death due
      to seizures.

      Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it
      reduces the risk of oxygen desaturation during the apneic period of the procedure. On room
      air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes
      following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to
      oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs
      from which transfer to the bloodstream can continue despite the lack of ventilation. The
      apneic episode during seizures should benefit from the same principle.

      The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better
      characterize seizures, to identify the main seizure focus. In addition to standard EEG with
      electrodes on the scalp, some patients require invasive localization of the epileptic focus
      by surgically placing electrodes within the skull (often referred to as GRID patients) on or
      within the brain, with the goal of being able to resect the area that is causing seizures. To
      identify where seizure originate electrically, it requires that seizures occur during the
      vEEG procedure. To provoke seizures, medications are typically lowered, and both partial
      seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will
      occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex
      partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use
      oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the investigators
      also have the capability for both for clinical usage.

      Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs
      following seizures as part of the post-ictal nursing care, though there is no outcome data to
      support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of
      oxygen desaturations clinically, as seen in animal models, and this is the goal of this
      research project.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oxygen desaturation below 92% following GTCs
time frame: during and up to 6 minutes following the seizure
measure: Oxygen Desaturations below 80% following GTCs
time frame: during and up to 6 minutes following seizures
arm group label: Pre-oxygenation first
arm group type: Experimental
description: st, 3rd, 5th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated
nd, 4th, 6th, etc seizure: Standard practice (O2 only in post-ictal period).
arm group label: Standard practice first
arm group type: Experimental
description: st, 3rd, 5th, etc seizure: Standard practice (O2 only in post-ictal period).
nd, 4th, 6th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated
intervention type: Other
intervention name: oxygen
description: O2 by nasal prongs
arm group label: Pre-oxygenation first
arm group label: Standard practice first
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Seizures