<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/NCT03010852</url>
  </required_header>
  <id_info>
    <org_study_id>16-1268</org_study_id>
    <nct_id>NCT03010852</nct_id>
  </id_info>
  <brief_title>Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery</brief_title>
  <official_title>Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are&#xD;
      common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and&#xD;
      even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its&#xD;
      success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on&#xD;
      patient compliance with IS effort and frequency. The investigators hypothesize that a focused&#xD;
      education preoperatively on IS for POH and intensive monitoring of patient compliance with IS&#xD;
      therapy in the early postoperative period shortens postoperative oxygen therapy, decreases&#xD;
      POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients&#xD;
      receiving standard of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">August 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of at least one episode of moderate/severe hypoxemic event</measure>
    <time_frame>During first post operative day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of postoperative oxygen therapy</measure>
    <time_frame>Up to 7 days after surgery</time_frame>
    <description>The duration of postoperative oxygen therapy will be evaluated from the arrival to the post-anesthesia care unit to successful discontinuation of oxygen therapy lasting greater than 2 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of postoperative oxygen therapy and postoperative hypoxemic events</measure>
    <time_frame>Up to 7 days after surgery</time_frame>
    <description>The development of postoperative hypoxemic events will be evaluated from the initiation of post-operative oxygen therapy through hospital discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Respiratory Complication</condition>
  <arm_group>
    <arm_group_label>Standard of care incentive spirometer</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the SOC cohort will not receive the preoperative education and only one postoperative visit per day to collect their self-reported use of IS, if prescribed, and respiratory symptoms but avoiding increasing their awareness of POH, O2 therapy and IS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Focused incentive spirometer education and monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One of the study investigators will meet eligible patients in the preoperative visit to the UCH Weight Loss Surgery clinic, inform and consent the patient and introduce the first education on IS therapy, highlighting its possible benefits and the importance of compliance (patient's inspiratory effort and frequency). This IS education will be repeated in the preoperative area immediately before surgery. The site will then follow the patient postoperatively. The site will directly check on the patient in the PACU and later in his/her hospital room at least 3 times a day during the first 3 days or sooner if their O2 therapy is discontinued for 2h. During these PO check ups The site will reinforce the IS use, monitor the patient's performance of IS and ask him/her about other respiratory symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Focused incentive spirometer education and monitoring</intervention_name>
    <arm_group_label>Focused incentive spirometer education and monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having planned elective bariatric surgery at University of Colorado Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency procedure&#xD;
&#xD;
          -  Oxygen therapy within the previous 30 days&#xD;
&#xD;
          -  Smoking within the previous 30 days&#xD;
&#xD;
          -  Inability or refusal to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Fernandez-Bustamante, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, School of Medicine - Department of Anesthesology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bariatric Surgery</keyword>
  <keyword>Spirometry Monitoring</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>N/A IPD will not be shared with other researchers</ipd_description>
  </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/NCT03010852
org study id: 16-1268
nct id: NCT03010852
lead sponsor: 
has dmc: No
Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are
      common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and
      even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its
      success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on
      patient compliance with IS effort and frequency. The investigators hypothesize that a focused
      education preoperatively on IS for POH and intensive monitoring of patient compliance with IS
      therapy in the early postoperative period shortens postoperative oxygen therapy, decreases
      POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients
      receiving standard of care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Frequency of at least one episode of moderate/severe hypoxemic event
time frame: During first post operative day
measure: Duration of postoperative oxygen therapy
time frame: Up to 7 days after surgery
description: The duration of postoperative oxygen therapy will be evaluated from the arrival to the post-anesthesia care unit to successful discontinuation of oxygen therapy lasting greater than 2 hours.
measure: Presence of postoperative oxygen therapy and postoperative hypoxemic events
time frame: Up to 7 days after surgery
description: The development of postoperative hypoxemic events will be evaluated from the initiation of post-operative oxygen therapy through hospital discharge.
arm group label: Standard of care incentive spirometer
arm group type: No Intervention
description: Patients in the SOC cohort will not receive the preoperative education and only one postoperative visit per day to collect their self-reported use of IS, if prescribed, and respiratory symptoms but avoiding increasing their awareness of POH, O2 therapy and IS.
arm group label: Focused incentive spirometer education and monitoring
arm group type: Experimental
description: One of the study investigators will meet eligible patients in the preoperative visit to the UCH Weight Loss Surgery clinic, inform and consent the patient and introduce the first education on IS therapy, highlighting its possible benefits and the importance of compliance (patient's inspiratory effort and frequency). This IS education will be repeated in the preoperative area immediately before surgery. The site will then follow the patient postoperatively. The site will directly check on the patient in the PACU and later in his/her hospital room at least 3 times a day during the first 3 days or sooner if their O2 therapy is discontinued for 2h. During these PO check ups The site will reinforce the IS use, monitor the patient's performance of IS and ask him/her about other respiratory symptoms.
intervention type: Behavioral
intervention name: Focused incentive spirometer education and monitoring
arm group label: Focused incentive spirometer education and monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ana Fernandez-Bustamante, M.D., Ph.D.
role: Principal Investigator
affiliation: University of Colorado, School of Medicine - Department of Anesthesology
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: N/A IPD will not be shared with other researchers