<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/NCT04440124</url>
  </required_header>
  <id_info>
    <org_study_id>JW01</org_study_id>
    <nct_id>NCT04440124</nct_id>
  </id_info>
  <brief_title>Does the Incremental Shuttle Walk Test Predict the Development of a Hospital Acquired Pneumonia in Patients Undergoing Elective Oesophagectomy: A Prospective Cohort Study</brief_title>
  <official_title>Does the Incremental Shuttle Walk Test Predict the Development of a Hospital Acquired Pneumonia in Patients Undergoing Elective Oesophagectomy: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Birmingham NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Birmingham NHS Foundation Trust</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>
      The purpose of this study was to assess the predictive value of the incremental shuttle walk&#xD;
      test on rates of hospital acquired pneumonia for patients undergoing oesophagectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Field tests to objectively measure functional capacity are becoming of greater importance&#xD;
      when looking to assess an individual's fitness for surgery. One such field test is the&#xD;
      incremental shuttle walk test (ISWT). An externally paced, maximal excursion test, the ISWT&#xD;
      is a simple and easily reproducible test that is widely used within cardiac and pulmonary&#xD;
      populations and shown to correlate well with Vo2 mas on a cardiopulmonary exercise test.&#xD;
      Previous studies looking at the benefit of the ISWT in predicting post-operative outcomes&#xD;
      within the oesophagastric population have demonstrated that walking less than 350 meters has&#xD;
      been associated with significantly higher rates of mortality at 30 days and 3 years. No&#xD;
      correlation between ISWT and postoperative respiratory complications in this surgical&#xD;
      population has been previously reported.&#xD;
&#xD;
      This study aims to assess whether walking &lt;350 meters on an ISWT predicts the development of&#xD;
      hospital acquired pneumonias following an elective oesophagectomy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</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>Hospital acquired pneumonia</measure>
    <time_frame>during hospital stay, on average 14 days</time_frame>
    <description>The incidence of hospital acquired pneumonia as defined by the US centres for Disease Control</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30 day Mortality</measure>
    <time_frame>30 days after date of surgery</time_frame>
    <description>Mortality rates 30 days post operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 day Mortality</measure>
    <time_frame>90 days following date of surgery</time_frame>
    <description>Mortality rates 90 days post operatively</description>
  </secondary_outcome>
  <enrollment type="Actual">121</enrollment>
  <condition>Oesophageal Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Incremental shuttle walk test</intervention_name>
    <description>All patients were reviewed by a physiotherapist during their pre-assessment clinic one week prior to surgery to complete an incremental shuttle walk test (ISWT). The ISWT was completed according to a standardised protocol and involved patients walking around 2 cones set up 9 metres apart. Patients were asked to cover the distance between the cones in time to auditory cues. Oxygen levels and heart rate were recorded during the assessment with the use of a portable pulse oximeter. The test was stopped when patients could no longer keep pace with the auditory cues or were too breathless to continue. The total distance mobilised was recorded.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing oesophagectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients with a diagnosis of oesophagogastric cancer listed for an&#xD;
             elective oesophagectomy at a large UK tertiary hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were unable to complete the walking test&#xD;
&#xD;
          -  patients deemed not fit for surgery&#xD;
&#xD;
          -  patients with a significant neurological event peri or post operatively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UHB NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2GW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Birmingham NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>David McWilliams</investigator_full_name>
    <investigator_title>Consultant Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>physiotherapy</keyword>
  <keyword>shuttle walk test</keyword>
  <keyword>hospital acquired pneumonia</keyword>
  <keyword>outcomes</keyword>
  <keyword>oesophagectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Healthcare-Associated Pneumonia</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/NCT04440124
org study id: JW01
nct id: NCT04440124
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to assess the predictive value of the incremental shuttle walk
      test on rates of hospital acquired pneumonia for patients undergoing oesophagectomy.
Field tests to objectively measure functional capacity are becoming of greater importance
      when looking to assess an individual's fitness for surgery. One such field test is the
      incremental shuttle walk test (ISWT). An externally paced, maximal excursion test, the ISWT
      is a simple and easily reproducible test that is widely used within cardiac and pulmonary
      populations and shown to correlate well with Vo2 mas on a cardiopulmonary exercise test.
      Previous studies looking at the benefit of the ISWT in predicting post-operative outcomes
      within the oesophagastric population have demonstrated that walking less than 350 meters has
      been associated with significantly higher rates of mortality at 30 days and 3 years. No
      correlation between ISWT and postoperative respiratory complications in this surgical
      population has been previously reported.

      This study aims to assess whether walking <350 meters on an ISWT predicts the development of
      hospital acquired pneumonias following an elective oesophagectomy
observational model: Cohort
time perspective: Prospective
measure: Hospital acquired pneumonia
time frame: during hospital stay, on average 14 days
description: The incidence of hospital acquired pneumonia as defined by the US centres for Disease Control
measure: 30 day Mortality
time frame: 30 days after date of surgery
description: Mortality rates 30 days post operatively
measure: 90 day Mortality
time frame: 90 days following date of surgery
description: Mortality rates 90 days post operatively
intervention type: Other
intervention name: Incremental shuttle walk test
description: All patients were reviewed by a physiotherapist during their pre-assessment clinic one week prior to surgery to complete an incremental shuttle walk test (ISWT). The ISWT was completed according to a standardised protocol and involved patients walking around 2 cones set up 9 metres apart. Patients were asked to cover the distance between the cones in time to auditory cues. Oxygen levels and heart rate were recorded during the assessment with the use of a portable pulse oximeter. The test was stopped when patients could no longer keep pace with the auditory cues or were too breathless to continue. The total distance mobilised was recorded.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University Hospital Birmingham NHS Foundation Trust
investigator full name: David McWilliams
investigator title: Consultant Physiotherapist
mesh term: Pneumonia
mesh term: Healthcare-Associated Pneumonia
sharing ipd: No