<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/NCT02238561</url>
  </required_header>
  <id_info>
    <org_study_id>14/P/123</org_study_id>
    <nct_id>NCT02238561</nct_id>
  </id_info>
  <brief_title>The Cost in Oxygen of Surgical Trauma</brief_title>
  <official_title>The Cost in Oxygen of Surgical Trauma (CO2ST) - a Feasibility Study of the Non-invasive Measurement of Oxygen Delivery and Consumption After Major Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Plymouth NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Plymouth NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will examine the relationship between post-operative oxygen consumption&#xD;
      (using non-invasive measurement technology ) and complications in patients having&#xD;
      contemporary major abdominal surgery. The investigators hypothesis is that major surgery may&#xD;
      trigger a physiological stress response that results in an increase in post-operative&#xD;
      metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen&#xD;
      delivery (DO2).&#xD;
&#xD;
        1. To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2)&#xD;
           using indirect calorimetry in a cohort of patients&#xD;
&#xD;
        2. To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in the&#xD;
           same cohort using non-invasive measures of cardiac output, oxygen saturation and&#xD;
           haemoglobin (pulse wave transit time and co-oximetry techniques)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective observational study of non-invasive measurements of V̇O2 and DO2 pre-operatively&#xD;
      and at 8 time points in the 48 hours postoperatively in a cohort of 40 patients undergoing&#xD;
      elective major abdominal surgery (both open and laparoscopic) with a pre-operative&#xD;
      cardiopulmonary exercise testing (CPET).&#xD;
&#xD;
      As pilot work examining the relationship between post-operative oxygen consumption and&#xD;
      complications in patients having contemporary major abdominal surgery , the investigators&#xD;
      need to define and grade the severity of complications. The Post-Operative Morbidity Survey&#xD;
      (POMS) is a simple outcome scale designed to record the incidence of clinically important&#xD;
      complications - specifically complications likely to keep a patient in hospital. A POMS score&#xD;
      performed on Day 5 is likely to be discriminative between patients who are recovering well,&#xD;
      and those who are developing complications. POMS is easily performed, has good internal&#xD;
      validity and is predictive of a prolonged length of stay. POMS is not a simple additive&#xD;
      scale; however patients with POMS score of 1 or greater are highly likely to remain in&#xD;
      hospital, whereas those with a score of 0 are likely to be able to go home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>postoperative morbidity score (POMS)</measure>
    <time_frame>Day 5 post surgery</time_frame>
    <description>The Post-Operative Morbidity Survey (POMS) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. A POMS score performed on Day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. POMS is easily performed, has good internal validity and is predictive of a prolonged length of stay. POMS is not a simple additive scale; however patients with POMS score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>estimated average length of hospital stay of 5 - 7 days</time_frame>
    <description>The number of days the patient is in hospital following surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned admission to critical care.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 5 - 7 days</time_frame>
    <description>We are looking at admission to critical care that was not arranged pre-operatively - a certain proportion of patients are routinely admitted to critical care because of medical co-morbidities. We are looking for those patients who were deemed fit enough not to need critical care post-operatively who subsequently need admission there, and the length of their stay there.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Returns to the operating theatre</measure>
    <time_frame>Number of events during Hospital admission (estimated average length of hospital stay of 5 - 7 days)</time_frame>
    <description>The number of times a patient has to be returned to the operating theatre during their index admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmission</measure>
    <time_frame>Within 30 days of discharge from hospital</time_frame>
    <description>Number of readmissions to hospital following discharge elated to the patients surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 30 days following hospital discharge</time_frame>
    <description>Patient mortality rate following surgery up to 30 days following discharge</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Oxygen Consumption (V̇O2)</condition>
  <condition>Oxygen Delivery (DO2)</condition>
  <condition>Post-operative Complications</condition>
  <arm_group>
    <arm_group_label>Elective major abdominal surgery</arm_group_label>
    <description>Patients undergoing elective major open or laparoscopic abdominal surgery at Plymouth Hospitals National Health Service (NHS) Trust (PHNT)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective major open or laparoscopic abdominal surgery at Plymouth&#xD;
        Hospitals NHS Trust (PHNT)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged 18 or over.&#xD;
&#xD;
          -  Undergoing elective major open or laparoscopic abdominal surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Requirement for post-operative ventilation&#xD;
&#xD;
          -  Requirement of inspired oxygen concentrations (FiO2) &gt; 28% to maintain oxygen&#xD;
             saturations ≥ 90%.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Kimble, BSc(Hons), MSc, MBBS, MRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Plymouth NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>October 29, 2015</last_update_submitted>
  <last_update_submitted_qc>October 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>non-invasive</keyword>
  <keyword>measurement of oxygen</keyword>
  <keyword>consumption</keyword>
  <keyword>delivery</keyword>
  <keyword>post-operative complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <!-- 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/NCT02238561
org study id: 14/P/123
nct id: NCT02238561
lead sponsor: 
has dmc: No
The investigators will examine the relationship between post-operative oxygen consumption
      (using non-invasive measurement technology ) and complications in patients having
      contemporary major abdominal surgery. The investigators hypothesis is that major surgery may
      trigger a physiological stress response that results in an increase in post-operative
      metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen
      delivery (DO2).

        1. To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2)
           using indirect calorimetry in a cohort of patients

        2. To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in the
           same cohort using non-invasive measures of cardiac output, oxygen saturation and
           haemoglobin (pulse wave transit time and co-oximetry techniques)
Prospective observational study of non-invasive measurements of V̇O2 and DO2 pre-operatively
      and at 8 time points in the 48 hours postoperatively in a cohort of 40 patients undergoing
      elective major abdominal surgery (both open and laparoscopic) with a pre-operative
      cardiopulmonary exercise testing (CPET).

      As pilot work examining the relationship between post-operative oxygen consumption and
      complications in patients having contemporary major abdominal surgery , the investigators
      need to define and grade the severity of complications. The Post-Operative Morbidity Survey
      (POMS) is a simple outcome scale designed to record the incidence of clinically important
      complications - specifically complications likely to keep a patient in hospital. A POMS score
      performed on Day 5 is likely to be discriminative between patients who are recovering well,
      and those who are developing complications. POMS is easily performed, has good internal
      validity and is predictive of a prolonged length of stay. POMS is not a simple additive
      scale; however patients with POMS score of 1 or greater are highly likely to remain in
      hospital, whereas those with a score of 0 are likely to be able to go home.
observational model: Cohort
time perspective: Prospective
measure: postoperative morbidity score (POMS)
time frame: Day 5 post surgery
description: The Post-Operative Morbidity Survey (POMS) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. A POMS score performed on Day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. POMS is easily performed, has good internal validity and is predictive of a prolonged length of stay. POMS is not a simple additive scale; however patients with POMS score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.
measure: Length of hospital stay
time frame: estimated average length of hospital stay of 5 - 7 days
description: The number of days the patient is in hospital following surgery
measure: Unplanned admission to critical care.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 - 7 days
description: We are looking at admission to critical care that was not arranged pre-operatively - a certain proportion of patients are routinely admitted to critical care because of medical co-morbidities. We are looking for those patients who were deemed fit enough not to need critical care post-operatively who subsequently need admission there, and the length of their stay there.
measure: Returns to the operating theatre
time frame: Number of events during Hospital admission (estimated average length of hospital stay of 5 - 7 days)
description: The number of times a patient has to be returned to the operating theatre during their index admission.
measure: Hospital readmission
time frame: Within 30 days of discharge from hospital
description: Number of readmissions to hospital following discharge elated to the patients surgery
measure: Mortality
time frame: Up to 30 days following hospital discharge
description: Patient mortality rate following surgery up to 30 days following discharge
arm group label: Elective major abdominal surgery
description: Patients undergoing elective major open or laparoscopic abdominal surgery at Plymouth Hospitals National Health Service (NHS) Trust (PHNT)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam Kimble, BSc(Hons), MSc, MBBS, MRCS
role: Principal Investigator
affiliation: University Hospital Plymouth NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Postoperative Complications