<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/NCT04411186</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00094011</org_study_id>
    <nct_id>NCT04411186</nct_id>
  </id_info>
  <brief_title>A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function</brief_title>
  <official_title>A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</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>
      The objective of this study is to determine whether the addition of lung protective&#xD;
      strategies to existing enhanced recovery after surgery (ERAS) protocols for colorectal&#xD;
      surgeries and hepatobiliary surgeries will improve post-operative lung function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2021</start_date>
  <completion_date type="Actual">September 21, 2021</completion_date>
  <primary_completion_date type="Actual">September 21, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inspiratory Capacity</measure>
    <time_frame>2 hours</time_frame>
    <description>The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation (SPO2) Trends</measure>
    <time_frame>2 hours</time_frame>
    <description>numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of supplemental Oxygen Requirements</measure>
    <time_frame>2 hours</time_frame>
    <description>Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Colorectal Surgery</condition>
  <condition>Hepatobiliary Surgery</condition>
  <arm_group>
    <arm_group_label>Standard Enhanced Recovery After Surgery (ERAS) Protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control for this study will be the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERAS and 5 Lung Protective Interventions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. The subject will also receive the following lung protective interventions:&#xD;
Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height)&#xD;
Positive end-expiratory pressure (PEEP) 7cm H2O5&#xD;
Immediately post intubation recruitment breath (30cm water for 30 seconds)&#xD;
Every 1 hour recruitment breath (30cm water for 30 seconds)&#xD;
40% FIO2 initially - titrate up as necessary to maintain SPO2 &gt;94%</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Enhanced Recovery After Surgery (ERAS) Protocol</intervention_name>
    <description>Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.</description>
    <arm_group_label>Standard Enhanced Recovery After Surgery (ERAS) Protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ERAS and 5 Lung Protective Interventions</intervention_name>
    <description>Subjects will receive the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. The subject will also receive the following lung protective interventions:&#xD;
Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height) Positive end-expiratory pressure (PEEP) 7cm H2O5 Immediately post intubation recruitment breath (30cm water for 30 seconds) Every 1 hour recruitment breath (30cm water for 30 seconds) 40% FIO2 initially - titrate up as necessary to maintain SPO2 &gt;94%</description>
    <arm_group_label>ERAS and 5 Lung Protective Interventions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects going for scheduled colorectal or hepatobiliary surgery at the MUSC ART&#xD;
             hospital who would normally be utilizing the existing ERAS protocols&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Ages 18 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency cases&#xD;
&#xD;
          -  Pregnant subjects-confirmed by pre-operative urine pregnancy test&#xD;
&#xD;
          -  Subjects with unique lung pathologies including, but not limited to: advanced&#xD;
             pulmonary fibrosis, lung transplantation recipients, end stage COPD, pulmonary&#xD;
             Hypertension&#xD;
&#xD;
          -  Subjects on home O2&#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>
  <overall_official>
    <last_name>David Gutman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>David Gutman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 29, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04411186
org study id: Pro00094011
nct id: NCT04411186
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to determine whether the addition of lung protective
      strategies to existing enhanced recovery after surgery (ERAS) protocols for colorectal
      surgeries and hepatobiliary surgeries will improve post-operative lung function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Inspiratory Capacity
time frame: 2 hours
description: The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.
measure: Oxygen Saturation (SPO2) Trends
time frame: 2 hours
description: numerical value for SPO2 trends in 15 min intervals in the Post Operative Care Unit (PACU)
measure: Incidence of supplemental Oxygen Requirements
time frame: 2 hours
description: Recording of use or lack thereof of supplemental oxygen in PACU in 15 minute intervals.
arm group label: Standard Enhanced Recovery After Surgery (ERAS) Protocol
arm group type: Active Comparator
description: Control for this study will be the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.
arm group label: ERAS and 5 Lung Protective Interventions
arm group type: Experimental
description: The standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. The subject will also receive the following lung protective interventions:
Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height)
Positive end-expiratory pressure (PEEP) 7cm H2O5
Immediately post intubation recruitment breath (30cm water for 30 seconds)
Every 1 hour recruitment breath (30cm water for 30 seconds)
40% FIO2 initially - titrate up as necessary to maintain SPO2 >94%
intervention type: Procedure
intervention name: Standard Enhanced Recovery After Surgery (ERAS) Protocol
description: Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.
arm group label: Standard Enhanced Recovery After Surgery (ERAS) Protocol
intervention type: Procedure
intervention name: ERAS and 5 Lung Protective Interventions
description: Subjects will receive the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. The subject will also receive the following lung protective interventions:
Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height) Positive end-expiratory pressure (PEEP) 7cm H2O5 Immediately post intubation recruitment breath (30cm water for 30 seconds) Every 1 hour recruitment breath (30cm water for 30 seconds) 40% FIO2 initially - titrate up as necessary to maintain SPO2 >94%
arm group label: ERAS and 5 Lung Protective Interventions
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Gutman, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: David Gutman
investigator title: Assistant Professor
sharing ipd: No
submitted: March 29, 2023