<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/NCT02193542</url>
  </required_header>
  <id_info>
    <org_study_id>bwhobanes-DADB</org_study_id>
    <nct_id>NCT02193542</nct_id>
  </id_info>
  <brief_title>Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients</brief_title>
  <acronym>DADB</acronym>
  <official_title>Prospective Observation Study of Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</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>
      Anesthesiologists commonly administer pain relief during labor or providing anesthesia for&#xD;
      cesarean delivery. Two main methods are used to achieve these goal: &quot;Regional anesthesia&quot;&#xD;
      where the mother is given medication through a needle or catheter in her back and the mother&#xD;
      is kept awake, or &quot;General anesthesia&quot;, where the mother is given intravenous medication and&#xD;
      is kept asleep.&#xD;
&#xD;
      Regional anesthesia uses a needle to enter a narrow space in the mother's back where&#xD;
      medications can be given. In some patients, it takes longer to find this target space in the&#xD;
      back. In emergency situation, however, there is often little time to find this space, and the&#xD;
      backup method would be the general anesthesia technique.&#xD;
&#xD;
      If general anesthesia is required, a breathing tube needs to be inserted to help support the&#xD;
      mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing&#xD;
      this in advanced helps anesthesiologists create a safe plan for the patients. A lot of&#xD;
      research has been done to determine factors that would predict which patients would need more&#xD;
      time and preparation for general anesthesia and regional anesthesia.&#xD;
&#xD;
      The purpose of this study is to study how common it is for the pregnant patients who have a&#xD;
      difficult regional and general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anesthesiologists commonly administer pain relief during labor or providing anesthesia for&#xD;
      cesarean delivery. Two main methods are used to achieve these goal: &quot;Regional anesthesia&quot;&#xD;
      where the mother is given medication through a needle or catheter in her back and the mother&#xD;
      is kept awake, or &quot;General anesthesia&quot;, where the mother is given intravenous medication and&#xD;
      is kept asleep.&#xD;
&#xD;
      Regional anesthesia uses a needle to enter a narrow space in the mother's back where&#xD;
      medications can be given. In some patients, it takes longer to find this target space in the&#xD;
      back. In emergency situation, however, there is often little time to find this space, and the&#xD;
      backup method would be the general anesthesia technique.&#xD;
&#xD;
      If general anesthesia is required, a breathing tube needs to be inserted to help support the&#xD;
      mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing&#xD;
      this in advanced helps anesthesiologists create a safe plan for the patients. A lot of&#xD;
      research has been done to determine factors that would predict which patients would need more&#xD;
      time and preparation for general anesthesia and regional anesthesia.&#xD;
&#xD;
      The purpose of this study is to study how common it is for the pregnant patients who have a&#xD;
      difficult regional and general anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>incidence of difficult regional and general anesthesia</measure>
    <time_frame>within 30 days</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered</condition>
  <arm_group>
    <arm_group_label>Pregnant patient</arm_group_label>
    <description>Pregnant woman presenting for vaginal or cesarean delivery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant woman presenting for vaginal or cesarean delivery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman presenting for vaginal or cesarean delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman presenting for vaginal or cesarean delivery requiring urgent or&#xD;
             emergent delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lawrence C Tsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony Chau, MD</last_name>
      <phone>617-732-5500</phone>
      <email>achau2@partners.org</email>
    </contact>
    <investigator>
      <last_name>Lawrence Tsen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anthony Chau, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carolina Bibbo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julian Robinson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric Cappiello, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097/00000542-200509000-00030. No abstract available.</citation>
    <PMID>16129992</PMID>
  </reference>
  <reference>
    <citation>Hawkins JL. Anesthesia-related maternal mortality. Clin Obstet Gynecol. 2003 Sep;46(3):679-87. doi: 10.1097/00003081-200309000-00020. No abstract available.</citation>
    <PMID>12972749</PMID>
  </reference>
  <reference>
    <citation>Ross BK. ASA closed claims in obstetrics: lessons learned. Anesthesiol Clin North Am. 2003 Mar;21(1):183-97. doi: 10.1016/s0889-8537(02)00051-2.</citation>
    <PMID>12698840</PMID>
  </reference>
  <reference>
    <citation>Ellinas EH, Eastwood DC, Patel SN, Maitra-D'Cruze AM, Ebert TJ. The effect of obesity on neuraxial technique difficulty in pregnant patients: a prospective, observational study. Anesth Analg. 2009 Oct;109(4):1225-31. doi: 10.1213/ANE.0b013e3181b5a1d2.</citation>
    <PMID>19762752</PMID>
  </reference>
  <reference>
    <citation>Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.</citation>
    <PMID>19420004</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Lawrence Ching Tsen</investigator_full_name>
    <investigator_title>Vice Chair, Faculty Development and Education; Director of Anesthesia, Center for Reproductive Medicine</investigator_title>
  </responsible_party>
  <keyword>regional anesthesia</keyword>
  <keyword>general anesthesia</keyword>
  <keyword>obstetric</keyword>
  <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/NCT02193542
org study id: bwhobanes-DADB
nct id: NCT02193542
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for
      cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia"
      where the mother is given medication through a needle or catheter in her back and the mother
      is kept awake, or "General anesthesia", where the mother is given intravenous medication and
      is kept asleep.

      Regional anesthesia uses a needle to enter a narrow space in the mother's back where
      medications can be given. In some patients, it takes longer to find this target space in the
      back. In emergency situation, however, there is often little time to find this space, and the
      backup method would be the general anesthesia technique.

      If general anesthesia is required, a breathing tube needs to be inserted to help support the
      mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing
      this in advanced helps anesthesiologists create a safe plan for the patients. A lot of
      research has been done to determine factors that would predict which patients would need more
      time and preparation for general anesthesia and regional anesthesia.

      The purpose of this study is to study how common it is for the pregnant patients who have a
      difficult regional and general anesthesia.
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for
      cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia"
      where the mother is given medication through a needle or catheter in her back and the mother
      is kept awake, or "General anesthesia", where the mother is given intravenous medication and
      is kept asleep.

      Regional anesthesia uses a needle to enter a narrow space in the mother's back where
      medications can be given. In some patients, it takes longer to find this target space in the
      back. In emergency situation, however, there is often little time to find this space, and the
      backup method would be the general anesthesia technique.

      If general anesthesia is required, a breathing tube needs to be inserted to help support the
      mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing
      this in advanced helps anesthesiologists create a safe plan for the patients. A lot of
      research has been done to determine factors that would predict which patients would need more
      time and preparation for general anesthesia and regional anesthesia.

      The purpose of this study is to study how common it is for the pregnant patients who have a
      difficult regional and general anesthesia.
observational model: Cohort
time perspective: Prospective
measure: incidence of difficult regional and general anesthesia
time frame: within 30 days
arm group label: Pregnant patient
description: Pregnant woman presenting for vaginal or cesarean delivery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lawrence C Tsen, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
citation: Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097/00000542-200509000-00030. No abstract available.
PMID: 16129992
citation: Hawkins JL. Anesthesia-related maternal mortality. Clin Obstet Gynecol. 2003 Sep;46(3):679-87. doi: 10.1097/00003081-200309000-00020. No abstract available.
PMID: 12972749
citation: Ross BK. ASA closed claims in obstetrics: lessons learned. Anesthesiol Clin North Am. 2003 Mar;21(1):183-97. doi: 10.1016/s0889-8537(02)00051-2.
PMID: 12698840
citation: Ellinas EH, Eastwood DC, Patel SN, Maitra-D'Cruze AM, Ebert TJ. The effect of obesity on neuraxial technique difficulty in pregnant patients: a prospective, observational study. Anesth Analg. 2009 Oct;109(4):1225-31. doi: 10.1213/ANE.0b013e3181b5a1d2.
PMID: 19762752
citation: Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093/bja/aep096. Epub 2009 May 6.
PMID: 19420004
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Lawrence Ching Tsen
investigator title: Vice Chair, Faculty Development and Education; Director of Anesthesia, Center for Reproductive Medicine
sharing ipd: No