<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/NCT03281408</url>
  </required_header>
  <id_info>
    <org_study_id>H17-01022</org_study_id>
    <nct_id>NCT03281408</nct_id>
  </id_info>
  <brief_title>Perioperative Complications and Myocardial Injury Risk in Arthoplasty Patients Suspected of Having Obstructive Sleep Apnea</brief_title>
  <official_title>Perioperative Obstructive Sleep Apnea Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vancouver Coastal Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive Sleep Apnea (OSA) is a common and under-diagnosed breathing disorder&#xD;
      characterized by recurrent partial or complete collapse of the upper airway (tongue, soft&#xD;
      palate) during sleep. It causes recurrent episodes of asphyxia (suffocation) resulting in&#xD;
      fragmented sleep, low blood oxygen levels (hypoxemia), and high carbon dioxide&#xD;
      concentrations. Untreated OSA is associated with serious heart/lung and metabolic diseases&#xD;
      including strokes, diabetes, and heart attacks.&#xD;
&#xD;
      When a patient with OSA undergoes surgery, the symptoms of OSA are exacerbated afterwards due&#xD;
      to the effects of anesthesia and related medications such as those used for pain control.&#xD;
      This puts patients at higher risk for complications and necessitates nursing care and&#xD;
      monitoring that are resource intensive. In many hospitals, patients with an OSA diagnosis are&#xD;
      monitored after surgery in &quot;high acuity&quot; wards where the nurse to patient ratio is higher&#xD;
      than usual. These high acuity/monitored beds are often in high demand, and their&#xD;
      unavailability may sometimes mean cancellation of surgery or prolonged patient stay in the&#xD;
      Post-operative Recovery Room, further causing operating room backlog.&#xD;
&#xD;
      Another serious issue is that many patients do not know they actually have the OSA condition.&#xD;
      It is estimated that up to 20% (1) of people in the general public have OSA and that 75% (2)&#xD;
      of them are not diagnosed. When someone with OSA goes for surgery without previously being&#xD;
      diagnosed, special precautions in care and monitoring may not be in place, until a&#xD;
      complication develops. For this reason, this population - those most susceptible to have OSA,&#xD;
      but with no previous formal testing for the condition - is the most at risk for&#xD;
      complications, and is the target group for this trial.&#xD;
&#xD;
      We plan to identify the study population by screening for OSA using the STOP-BANG&#xD;
      questionnaire. Those who score high on this 8 item screening test have high likelihood of&#xD;
      actually having OSA if they were to undergo formal testing and diagnosis in a Sleep Lab.&#xD;
&#xD;
      We will identify cardio-respiratory complications by conducting a chart review and determine&#xD;
      whether admission to a &quot;high acuity&quot; bed had any impact. As OSA patients are at higher risk&#xD;
      for cardiovascular complications at baseline and around the time of surgery, blood test for&#xD;
      troponin will be performed on post-op day 1 and 2 to investigate the rate of myocardial&#xD;
      injury. With the rate of MINS (myocardial injury after non-cardiac surgery) reported to be 8%&#xD;
      with almost 10% 30 day mortality (per VISION trial), this pilot project which focuses on&#xD;
      arthroplasty patients with suspected OSA, will inform us of the arthroplasty surgery specific&#xD;
      MINS risk for comparison.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">October 12, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>Composite Adverse Events</measure>
    <time_frame>0-96 hours</time_frame>
    <description>The incidence of adverse events (each listed as a secondary outcome) related to OSA combined as a composite end point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Troponin</measure>
    <time_frame>Post-op Day 1</time_frame>
    <description>Testing for risk of MINS (myocardial injury after non-cardiac surgery)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Troponin</measure>
    <time_frame>Post-op Day 2</time_frame>
    <description>Testing for risk of MINS (myocardial injury after non-cardiac surgery)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory or Cardiac Arrest</measure>
    <time_frame>0-96 hours</time_frame>
    <description>Activation of Code Blue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Therapy beyond standard nasal prong oxygen</measure>
    <time_frame>0-96 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pneumonia</measure>
    <time_frame>0-96 hours</time_frame>
    <description>Fever with temp &gt;=38 degree Celsius, leukocytosis and new infiltrate on CXR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Naloxone Usage</measure>
    <time_frame>0-96 hours</time_frame>
    <description>For opioid reversal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway Intervention for any cause</measure>
    <time_frame>0-96 hours</time_frame>
    <description>Use of nasal/oral airway or intubation, jaw thrust/chin lift</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Arrhythmia</measure>
    <time_frame>0-96 hours</time_frame>
    <description>New arrhythmia requiring treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac ischemia or injury</measure>
    <time_frame>0-48 hours</time_frame>
    <description>ECG changes or troponin elevation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer from normal ward bed to monitored bed</measure>
    <time_frame>0-96 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer to local tertiary hospital</measure>
    <time_frame>0-96 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>30 Day Mortality</measure>
    <time_frame>30 days</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Suspected OSA Patients Undergoing Knee or Hip Arthroplasty</arm_group_label>
    <description>These 100 subjects will be cared for and monitored in hospital following current hospital protocol. No change or intervention is to be administered. Troponin testing will be done post-op with other routine blood work.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to the UBC Hospital to have knee/hip arthroplasty surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing elective primary or revision knee/hip replacement surgery.&#xD;
&#xD;
          2. Patients with no previous OSA diagnosis (by polysomnography), who score &gt;=5 on&#xD;
             STOP-BANG OSA screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients without ability to communicate in English by reading or writing.&#xD;
&#xD;
          2. Patients with renal failure.&#xD;
&#xD;
          3. Patients on CPAP therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UBC Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.</citation>
    <PMID>23589584</PMID>
  </reference>
  <reference>
    <citation>Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.</citation>
    <PMID>18250205</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Steven Lee</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT03281408
org study id: H17-01022
nct id: NCT03281408
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Obstructive Sleep Apnea (OSA) is a common and under-diagnosed breathing disorder
      characterized by recurrent partial or complete collapse of the upper airway (tongue, soft
      palate) during sleep. It causes recurrent episodes of asphyxia (suffocation) resulting in
      fragmented sleep, low blood oxygen levels (hypoxemia), and high carbon dioxide
      concentrations. Untreated OSA is associated with serious heart/lung and metabolic diseases
      including strokes, diabetes, and heart attacks.

      When a patient with OSA undergoes surgery, the symptoms of OSA are exacerbated afterwards due
      to the effects of anesthesia and related medications such as those used for pain control.
      This puts patients at higher risk for complications and necessitates nursing care and
      monitoring that are resource intensive. In many hospitals, patients with an OSA diagnosis are
      monitored after surgery in "high acuity" wards where the nurse to patient ratio is higher
      than usual. These high acuity/monitored beds are often in high demand, and their
      unavailability may sometimes mean cancellation of surgery or prolonged patient stay in the
      Post-operative Recovery Room, further causing operating room backlog.

      Another serious issue is that many patients do not know they actually have the OSA condition.
      It is estimated that up to 20% (1) of people in the general public have OSA and that 75% (2)
      of them are not diagnosed. When someone with OSA goes for surgery without previously being
      diagnosed, special precautions in care and monitoring may not be in place, until a
      complication develops. For this reason, this population - those most susceptible to have OSA,
      but with no previous formal testing for the condition - is the most at risk for
      complications, and is the target group for this trial.

      We plan to identify the study population by screening for OSA using the STOP-BANG
      questionnaire. Those who score high on this 8 item screening test have high likelihood of
      actually having OSA if they were to undergo formal testing and diagnosis in a Sleep Lab.

      We will identify cardio-respiratory complications by conducting a chart review and determine
      whether admission to a "high acuity" bed had any impact. As OSA patients are at higher risk
      for cardiovascular complications at baseline and around the time of surgery, blood test for
      troponin will be performed on post-op day 1 and 2 to investigate the rate of myocardial
      injury. With the rate of MINS (myocardial injury after non-cardiac surgery) reported to be 8%
      with almost 10% 30 day mortality (per VISION trial), this pilot project which focuses on
      arthroplasty patients with suspected OSA, will inform us of the arthroplasty surgery specific
      MINS risk for comparison.
observational model: Cohort
time perspective: Prospective
measure: Composite Adverse Events
time frame: 0-96 hours
description: The incidence of adverse events (each listed as a secondary outcome) related to OSA combined as a composite end point
measure: Troponin
time frame: Post-op Day 1
description: Testing for risk of MINS (myocardial injury after non-cardiac surgery)
measure: Troponin
time frame: Post-op Day 2
description: Testing for risk of MINS (myocardial injury after non-cardiac surgery)
measure: Respiratory or Cardiac Arrest
time frame: 0-96 hours
description: Activation of Code Blue
measure: Respiratory Therapy beyond standard nasal prong oxygen
time frame: 0-96 hours
measure: Pneumonia
time frame: 0-96 hours
description: Fever with temp >=38 degree Celsius, leukocytosis and new infiltrate on CXR
measure: Naloxone Usage
time frame: 0-96 hours
description: For opioid reversal
measure: Airway Intervention for any cause
time frame: 0-96 hours
description: Use of nasal/oral airway or intubation, jaw thrust/chin lift
measure: Cardiac Arrhythmia
time frame: 0-96 hours
description: New arrhythmia requiring treatment
measure: Cardiac ischemia or injury
time frame: 0-48 hours
description: ECG changes or troponin elevation
measure: Transfer from normal ward bed to monitored bed
time frame: 0-96 hours
measure: Transfer to local tertiary hospital
time frame: 0-96 hours
measure: 30 Day Mortality
time frame: 30 days
arm group label: Suspected OSA Patients Undergoing Knee or Hip Arthroplasty
description: These 100 subjects will be cared for and monitored in hospital following current hospital protocol. No change or intervention is to be administered. Troponin testing will be done post-op with other routine blood work.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
citation: Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
PMID: 23589584
citation: Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.
PMID: 18250205
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Steven Lee
investigator title: Clinical Assistant Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No