<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/NCT03815097</url>
  </required_header>
  <id_info>
    <org_study_id>CooperHS</org_study_id>
    <nct_id>NCT03815097</nct_id>
  </id_info>
  <brief_title>Prospective Study to Evaluate Mapleson Circuit With Monitored Anesthesia Care During Endobronchial Ultrasound (EBUS) Bronchoscopy</brief_title>
  <official_title>Prospective Study to Evaluate Mapleson Circuit With Monitored Anesthesia Care During EBUS Bronchoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cooper Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cooper Health System</source>
  <oversight_info>
    <has_dmc>Yes</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>
      If the investigators can prove that the use of a mapleson circuit attached to a nasal trumpet&#xD;
      employed during monitored anesthesia care leads to less sedation requirements, less procedure&#xD;
      interruptions, shorter procedure duration, this would allow for to standardization of the&#xD;
      type of anesthetic employed for EBUS at the investigators' institution and elsewhere. Less&#xD;
      hypoxic episodes and less anesthetic requirements would benefit outcomes, lead to less&#xD;
      recovery time and earlier discharges. Shorter procedural duration will create greater&#xD;
      efficiency in the short procedure unit where the EBUS are performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monitored anesthesia Care (MAC) is a type of conscious sedation delivered by an&#xD;
      anesthesiologist, during which different medications are given, usually via the intravenous&#xD;
      route, to obtain varying levels of sedation depending on the surgery or procedure. This is&#xD;
      routinely done for all EBUS procedures at Cooper University Hospital. Since MAC anesthesia&#xD;
      does not include having a secure airway, occasionally the patient may develop episodes in&#xD;
      which their oxygen level drops. During these episodes, the anesthesiologist will stop the&#xD;
      procedure temporarily until the oxygen level returns to a normal range.&#xD;
&#xD;
      Often, changes in sedation amount is also required during this time. In traditional MAC&#xD;
      anesthesia, the patient is receiving oxygen via a nasal cannula or a mask capable of&#xD;
      measuring capnography. If oxygen is delivered via a capnography mask, the routine is to&#xD;
      create a hole with scissors in the side of the mask in order to allow the bronchoscope into&#xD;
      the patient's mouth. The Mapleson Circuit is a breathing system used to deliver oxygen and&#xD;
      remove carbon dioxide during anesthesia. It consists of fresh oxygen flow, a reservoir bag,&#xD;
      an expiratory valve, tubing, and a connection to the patient. There are different types of&#xD;
      Mapleson circuits depending on the different arrangements of its components. The&#xD;
      investigators plan to use a Mapleson D circuit attached to a nasal trumpet via a connector.&#xD;
&#xD;
      Endobronchial Ultrasound is a technique that uses ultrasound along with bronchoscopy to&#xD;
      visualize the airway wall and structures adjacent to it. The clinical application and&#xD;
      diagnostic benefits of EBUS have been well established, including diagnosis and staging of&#xD;
      lung cancer. EBUS is usually performed under conscious sedation for patient comfort.&#xD;
&#xD;
      The route of entry for the EBUS scope requires passage through the vocal cords and into the&#xD;
      airways. The procedure tends to be very stimulating for this reason, which is the reason for&#xD;
      the necessity for anesthesia. Due to the amount of anesthesia required to subdue the airway&#xD;
      reflexes for a smooth procedure, occasionally, the patient may become apneic or obstruct and&#xD;
      not take adequate tidal volume breaths, leading to hypoxia. During these instances, the&#xD;
      procedure is halted until the patient's oxygen levels return to baseline. The investigators&#xD;
      have noticed that anesthesiologists who prefer to use the mapleson circuit with a nasal&#xD;
      trumpet in place tend to less often interrupt the procedure due to hypoxia.&#xD;
&#xD;
      Placing a nasal trumpet in one nare allows access to the oropharynx, bypassing soft tissue&#xD;
      that may relax under anesthesia and cause obstruction. Connecting that nasal trumpet to a&#xD;
      device that can not only deliver oxygen efficiently when the subject is spontaneously&#xD;
      breathing, but can also be used as an assist device to deliver assisted breaths in the event&#xD;
      that the patient becomes hypoxic or apneic provides a method to oxygenate into the oropharynx&#xD;
      without having to interrupt the procedure. It also helps maintain an airway from the nares&#xD;
      into the oropharynx and prevent episodes of obstruction, which are commonly seen under MAC&#xD;
      anesthesia. All anesthesiologists are familiar with the mapleson circuits as well as nasal&#xD;
      trumpets.&#xD;
&#xD;
      No research has been done in this field specifically regarding EBUS. There is no anesthetic&#xD;
      standard of care that is specific for an EBUS procedure. The anesthesia can be local&#xD;
      anesthesia alone, with just topicalization of the airways, or MAC, or even general anesthesia&#xD;
      with an endotracheal tube or a laryngeal mask airway. The choice is practitioner dependent.&#xD;
&#xD;
      Our experience has been that MAC with a mapleson circuit leads to less procedural&#xD;
      interruptions, less hypoxic episodes and shorter procedural duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">October 30, 2015</completion_date>
  <primary_completion_date type="Actual">October 30, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective, randomized study. The study will not be blinded. Subjects will be recruited from those who are referred to the interventional pulmonary department for EBUS bronchoscopy and who will be undergoing monitored anesthesia care (MAC) for their procedure. Subjects will then be randomized (via an computer randomizing algorithm) to receive conventional MAC vs. MAC with a mapleson circuit and nasal trumpet.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Interruptions of the procedures for any respiratory events</measure>
    <time_frame>2 years</time_frame>
    <description>An interruption is defined as any respiratory event that requires an intervention by the anesthesia provider or one requiring the procedural physician to temporarily stop the procedure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Adenopathy; Localized</condition>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monitored anesthesia care with a mapleson circuit and nasal trumpet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard monitored anesthesia care</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mapleson circuit and nasal trumpet</intervention_name>
    <description>The Mapleson Circuit is a breathing system used to deliver oxygen and remove carbon dioxide during anesthesia. It consists of fresh oxygen flow, a reservoir bag, an expiratory valve, tubing, and a connection to the patient. There are different types of Mapleson circuits depending on the different arrangements of its components. We plan to use a Mapleson D circuit attached to a nasal trumpet via a connector.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&gt; 18&#xD;
&#xD;
          2. Patient undergoing EBUS bronchoscopy&#xD;
&#xD;
          3. Patient undergoing moderate conscious sedation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects age &lt;18&#xD;
&#xD;
          2. Subjects requiring general anesthesia&#xD;
&#xD;
          3. Subjects with previous nasal surgeries&#xD;
&#xD;
          4. Subjects with Oxygen saturation &lt; 90% on room air prior to procedure&#xD;
&#xD;
          5. Subjects who are pregnant&#xD;
&#xD;
          6. Subjects with known facial fractures or recent facial trauma&#xD;
&#xD;
          7. Subjects on any anticoagulation that cannot be discontinued prior to the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphadenopathy</mesh_term>
  </condition_browse>
  <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/NCT03815097
org study id: CooperHS
nct id: NCT03815097
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
If the investigators can prove that the use of a mapleson circuit attached to a nasal trumpet
      employed during monitored anesthesia care leads to less sedation requirements, less procedure
      interruptions, shorter procedure duration, this would allow for to standardization of the
      type of anesthetic employed for EBUS at the investigators' institution and elsewhere. Less
      hypoxic episodes and less anesthetic requirements would benefit outcomes, lead to less
      recovery time and earlier discharges. Shorter procedural duration will create greater
      efficiency in the short procedure unit where the EBUS are performed.
Monitored anesthesia Care (MAC) is a type of conscious sedation delivered by an
      anesthesiologist, during which different medications are given, usually via the intravenous
      route, to obtain varying levels of sedation depending on the surgery or procedure. This is
      routinely done for all EBUS procedures at Cooper University Hospital. Since MAC anesthesia
      does not include having a secure airway, occasionally the patient may develop episodes in
      which their oxygen level drops. During these episodes, the anesthesiologist will stop the
      procedure temporarily until the oxygen level returns to a normal range.

      Often, changes in sedation amount is also required during this time. In traditional MAC
      anesthesia, the patient is receiving oxygen via a nasal cannula or a mask capable of
      measuring capnography. If oxygen is delivered via a capnography mask, the routine is to
      create a hole with scissors in the side of the mask in order to allow the bronchoscope into
      the patient's mouth. The Mapleson Circuit is a breathing system used to deliver oxygen and
      remove carbon dioxide during anesthesia. It consists of fresh oxygen flow, a reservoir bag,
      an expiratory valve, tubing, and a connection to the patient. There are different types of
      Mapleson circuits depending on the different arrangements of its components. The
      investigators plan to use a Mapleson D circuit attached to a nasal trumpet via a connector.

      Endobronchial Ultrasound is a technique that uses ultrasound along with bronchoscopy to
      visualize the airway wall and structures adjacent to it. The clinical application and
      diagnostic benefits of EBUS have been well established, including diagnosis and staging of
      lung cancer. EBUS is usually performed under conscious sedation for patient comfort.

      The route of entry for the EBUS scope requires passage through the vocal cords and into the
      airways. The procedure tends to be very stimulating for this reason, which is the reason for
      the necessity for anesthesia. Due to the amount of anesthesia required to subdue the airway
      reflexes for a smooth procedure, occasionally, the patient may become apneic or obstruct and
      not take adequate tidal volume breaths, leading to hypoxia. During these instances, the
      procedure is halted until the patient's oxygen levels return to baseline. The investigators
      have noticed that anesthesiologists who prefer to use the mapleson circuit with a nasal
      trumpet in place tend to less often interrupt the procedure due to hypoxia.

      Placing a nasal trumpet in one nare allows access to the oropharynx, bypassing soft tissue
      that may relax under anesthesia and cause obstruction. Connecting that nasal trumpet to a
      device that can not only deliver oxygen efficiently when the subject is spontaneously
      breathing, but can also be used as an assist device to deliver assisted breaths in the event
      that the patient becomes hypoxic or apneic provides a method to oxygenate into the oropharynx
      without having to interrupt the procedure. It also helps maintain an airway from the nares
      into the oropharynx and prevent episodes of obstruction, which are commonly seen under MAC
      anesthesia. All anesthesiologists are familiar with the mapleson circuits as well as nasal
      trumpets.

      No research has been done in this field specifically regarding EBUS. There is no anesthetic
      standard of care that is specific for an EBUS procedure. The anesthesia can be local
      anesthesia alone, with just topicalization of the airways, or MAC, or even general anesthesia
      with an endotracheal tube or a laryngeal mask airway. The choice is practitioner dependent.

      Our experience has been that MAC with a mapleson circuit leads to less procedural
      interruptions, less hypoxic episodes and shorter procedural duration.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: This is a prospective, randomized study. The study will not be blinded. Subjects will be recruited from those who are referred to the interventional pulmonary department for EBUS bronchoscopy and who will be undergoing monitored anesthesia care (MAC) for their procedure. Subjects will then be randomized (via an computer randomizing algorithm) to receive conventional MAC vs. MAC with a mapleson circuit and nasal trumpet.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Interruptions of the procedures for any respiratory events
time frame: 2 years
description: An interruption is defined as any respiratory event that requires an intervention by the anesthesia provider or one requiring the procedural physician to temporarily stop the procedure.
arm group label: Intervention
arm group type: Experimental
description: Monitored anesthesia care with a mapleson circuit and nasal trumpet
arm group label: Standard of care
arm group type: No Intervention
description: Standard monitored anesthesia care
intervention type: Procedure
intervention name: Mapleson circuit and nasal trumpet
description: The Mapleson Circuit is a breathing system used to deliver oxygen and remove carbon dioxide during anesthesia. It consists of fresh oxygen flow, a reservoir bag, an expiratory valve, tubing, and a connection to the patient. There are different types of Mapleson circuits depending on the different arrangements of its components. We plan to use a Mapleson D circuit attached to a nasal trumpet via a connector.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Lymphadenopathy
sharing ipd: No