xml: <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/NCT05978635</url>
    </required_header>
    <id_info>
      <org_study_id>16D.091</org_study_id>
      <nct_id>NCT05978635</nct_id>
    </id_info>
    <brief_title>Goal Directed Numeric Coaching as a Means of Preoxygenation</brief_title>
    <official_title>Goal Directed Numeric Coaching as a Means of Preoxygenation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Thomas Jefferson University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Thomas Jefferson University</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>
        Pre-oxygenation is an anesthetic technique that allows for extended apneic (suspension of&#xD;
        breathing) time prior to attempted endotracheal intubation. A common method to achieve&#xD;
        adequate pre-oxygenation is having a patient take four vital capacity breaths of 100% oxygen&#xD;
        in thirty seconds. This study seeks to determine if goal directed numeric coaching can lead&#xD;
        to more accurate vital capacities during this technique.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 17, 2016</start_date>
    <completion_date type="Actual">December 20, 2018</completion_date>
    <primary_completion_date type="Actual">December 20, 2018</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Once an adequate seal with consistent end tidal carbon dioxide on capnography is achieved, time starts. Patients are divided into two groups:&#xD;
  Group A: Anesthesia provider encourages patient to breathe deeply by intermittently stating &quot;take as deep a breath as you can&quot;. No goal directed numeric coaching is given. End point is 80% expired oxygen. The time it takes to achieve this end point and breath volumes are recorded.&#xD;
  Group B: Anesthesia provider gives goal directed numeric coaching. For example, if the initial tidal volume achieved by the patient is 500mL, the provider states, &quot;that was a 500mL breath, now try to achieve a 1000mL breath&quot;. The numeric goal should continue to increase above the patient's actual tidal volume (volume moved in and out of lungs during normal, quiet breathing) until an end point of 80% is reached. The time it takes to achieve this end point and breath volumes are recorded.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Vital capacity breaths measured in milliliters</measure>
      <time_frame>Pre oxygenation period prior to induction of general anesthesia</time_frame>
      <description>Measured vital capacity breaths volume in milliliters</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">86</enrollment>
    <condition>Pre-oxygenation</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Anesthesia provider asks the patient to take 4 deep breaths by intermittently stating &quot;take as deep a breath as you can&quot;. This is the standard of care technique for preoxygenation before induction of general anesthesia with the end point being 80% expired oxygen. The breath volumes in milliliters are recorded but not stated to the patient.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Anesthesia provider asks the patient to take 4 deep breaths but provides coaching by informing the patient of the numeric volume (milliliters) to reach for every breath. Each tidal volume breath is measured using the anesthesia ventilator and the provider encourages the patient to achieve a higher tidal volume than previously achieved. For example, if the initial tidal volume achieved by the patient is 500 milliliter, the provider states, &quot;that was a 500 milliliter breath, now try to achieve a 1000mL breath&quot;. The numeric goal should continue to increase above the patient's actual tidal volume. The breath volumes are recorded.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Group A Standard 4 deep breaths measured in milliliters from the ventilator.</intervention_name>
      <description>Tidal volume breath measured in milliliters</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Group B Coached 4 deep breaths measured in milliliters from the ventilator</intervention_name>
      <description>Coached tidal volume breath measured in milliliters</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists Physical Status 1 and 2&#xD;
  &#xD;
            -  nonsmokers&#xD;
  &#xD;
            -  primary English speaking&#xD;
  &#xD;
            -  undergoing elective surgery with planned endotracheal intubation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Thomas Jefferson University</investigator_affiliation>
      <investigator_full_name>Stephen McNulty</investigator_full_name>
      <investigator_title>Doctor of Osteopathic Medicine</investigator_title>
    </responsible_party>
    <keyword>Pre-oxygenation, vital capacity breaths</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978635
  org study id: 16D.091
  nct id: NCT05978635
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pre-oxygenation is an anesthetic technique that allows for extended apneic (suspension of
        breathing) time prior to attempted endotracheal intubation. A common method to achieve
        adequate pre-oxygenation is having a patient take four vital capacity breaths of 100% oxygen
        in thirty seconds. This study seeks to determine if goal directed numeric coaching can lead
        to more accurate vital capacities during this technique.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Once an adequate seal with consistent end tidal carbon dioxide on capnography is achieved, time starts. Patients are divided into two groups:
  Group A: Anesthesia provider encourages patient to breathe deeply by intermittently stating "take as deep a breath as you can". No goal directed numeric coaching is given. End point is 80% expired oxygen. The time it takes to achieve this end point and breath volumes are recorded.
  Group B: Anesthesia provider gives goal directed numeric coaching. For example, if the initial tidal volume achieved by the patient is 500mL, the provider states, "that was a 500mL breath, now try to achieve a 1000mL breath". The numeric goal should continue to increase above the patient's actual tidal volume (volume moved in and out of lungs during normal, quiet breathing) until an end point of 80% is reached. The time it takes to achieve this end point and breath volumes are recorded.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Vital capacity breaths measured in milliliters
  time frame: Pre oxygenation period prior to induction of general anesthesia
  description: Measured vital capacity breaths volume in milliliters
  arm group label: Group A
  arm group type: Placebo Comparator
  description: Anesthesia provider asks the patient to take 4 deep breaths by intermittently stating "take as deep a breath as you can". This is the standard of care technique for preoxygenation before induction of general anesthesia with the end point being 80% expired oxygen. The breath volumes in milliliters are recorded but not stated to the patient.
  arm group label: Group B
  arm group type: Experimental
  description: Anesthesia provider asks the patient to take 4 deep breaths but provides coaching by informing the patient of the numeric volume (milliliters) to reach for every breath. Each tidal volume breath is measured using the anesthesia ventilator and the provider encourages the patient to achieve a higher tidal volume than previously achieved. For example, if the initial tidal volume achieved by the patient is 500 milliliter, the provider states, "that was a 500 milliliter breath, now try to achieve a 1000mL breath". The numeric goal should continue to increase above the patient's actual tidal volume. The breath volumes are recorded.
  intervention type: Behavioral
  intervention name: Group A Standard 4 deep breaths measured in milliliters from the ventilator.
  description: Tidal volume breath measured in milliliters
  arm group label: Group A
  intervention type: Behavioral
  intervention name: Group B Coached 4 deep breaths measured in milliliters from the ventilator
  description: Coached tidal volume breath measured in milliliters
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Thomas Jefferson University
  investigator full name: Stephen McNulty
  investigator title: Doctor of Osteopathic Medicine
  sharing ipd: No