<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/NCT03795467</url>
  </required_header>
  <id_info>
    <nct_id>NCT03795467</nct_id>
  </id_info>
  <brief_title>Peripheral Perfusion Index, Haemoglobin and Blood Transfusion in Acute Surgical Patients</brief_title>
  <official_title>Association Between the Peripheral Perfusion Index, Haemoglobin Levels and Blood Transfusions in Patients Undergoing Acute Abdominal- and Orthopaedic Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</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 peripheral perfusion index (PPI) is a non-invasive, feasible measure of peripheral&#xD;
      perfusion and, assumed, the overall circulation, which all patients are monitored by.&#xD;
&#xD;
      This study is carried out to assess the association between values of PPI, haemoglobin and&#xD;
      blood transfusion.&#xD;
&#xD;
      Hypothetically, patients with low values of hb are more susceptible to a deteriorating&#xD;
      circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with&#xD;
      blood products improves PPI measurements. Moreover, that patients with low values of PPI have&#xD;
      more surgical complications and higher mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Acute surgical patients with e.g. hip fracture (HF) or acute abdominal surgical&#xD;
      conditions often have comorbidities and a fragile circulation. Haemodynamic challenges make&#xD;
      these patients vulnerable during anaesthesia, and perioperative complications are frequent.&#xD;
&#xD;
      Anaemia is associated with increased mortality and adverse outcomes in patients undergoing&#xD;
      surgery. One of the consequences of acute anaemia is reduced blood oxygen content, leading to&#xD;
      reduced tissue oxygen delivery and development of tissue hypoxia. Patients with e.g. HF have&#xD;
      a large drop in haemoglobin (hb) level that occurs after the injury, yet prior to the&#xD;
      surgery. It is therefore important to be aware of the risk of preoperative anaemia even when&#xD;
      the initial hb levels appear to be normal. Perioperative hb are associated with shorter&#xD;
      lengths of hospital stay, reduced mortality and lower readmission rates, and patients with&#xD;
      postoperative anaemia have increased mortality and length of hospital stay.&#xD;
&#xD;
      Haemodynamic monitoring is traditionally based on measurement of blood pressure (BP) and&#xD;
      heart rate (HR) but these measurements may be insufficient in evaluating overall oxygen&#xD;
      delivery and perfusion of vital organs. An apparently sufficient BP and, for patients with&#xD;
      more specialised monitoring, cardiac output (CO), does not necessarily mean a sufficient&#xD;
      peripheral microcirculatory flow due to compensatory mechanisms, but on the other hand a low&#xD;
      CO may be sufficient in context of low metabolic demand.&#xD;
&#xD;
      The non-invasive peripheral perfusion index (PPI) is a numerical value of peripheral&#xD;
      perfusion measured by the pulse oximeter derived from the photoelectric plethysmographic&#xD;
      signal. PPI is represents the ratio between the pulsatile component (arterial) and the&#xD;
      non-pulsatile component (venous blood, capillary blood and other tissues) of the light&#xD;
      reaching the detector of the pulse oximeter, and reflects changes in peripheral blood flow as&#xD;
      the pulsatile component increases with vasodilatation and decreases with vasoconstriction. It&#xD;
      is an accessible way to obtain a measure for peripheral perfusion as pulse oximeters are&#xD;
      universally available in all operating rooms and intensive care units. Previous studies have&#xD;
      shown that PPI is a useful indicator of reduced peripheral blood flow both in clinical and&#xD;
      experimental settings. Correlation between clinical symptoms of reduced peripheral perfusion&#xD;
      such as low temperature, increased capillary response and reduced PPI in critically ill&#xD;
      patients has been demonstrated, and a reduced peripheral perfusion may be a predictor of&#xD;
      mortality and complications in patients undergoing major surgical procedures and in septic&#xD;
      shock patients.&#xD;
&#xD;
      Hypothetically, patients with low values of hb are more susceptible to a deteriorating&#xD;
      circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with&#xD;
      blood products improves PPI measurements. Moreover, that patients with low values of PPI have&#xD;
      more surgical complications and higher mortality.&#xD;
&#xD;
      Method: The main objective of this study is to estimate the association between perioperative&#xD;
      values of PPI and haemoglobin levels. The secondary objectives are to evaluate PPI in&#xD;
      patients with low hb in relation to mean arterial blood pressure (MAP), and evaluate changes&#xD;
      in PPI with patients with low and normal hb in relation to transfusion with blood products.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Peripheral perfusion index</measure>
    <time_frame>Perioperative with 5 minute interval</time_frame>
    <description>Absolute PPI levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Haemoglobin level</measure>
    <time_frame>Time interval: From 3 hours preoperative to 10 hours postoperative</time_frame>
    <description>Measurement of haemoglobin by blood sample or artery gas.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Peripheral perfusion index in patients with high vs. low haemoglobin levels in relation to mean arterial blood pressure (MAP).</measure>
    <time_frame>Perioperative</time_frame>
    <description>High vs. low hb defined as 6,0 &lt; hb &gt; 6,0. Absolute PPI levels perioperative with a 5 minute interval. Absolute values of MAP measured perioperative with a 5 minute interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of transfusion with blood products in patients with perioperative high vs. low haemoglobin levels.</measure>
    <time_frame>Perioperative</time_frame>
    <description>High vs. low hb defined as 6,0 &lt; hb &gt; 6,0. Blood transfusion measured as total amount used perioperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of peripheral perfusion index changes in patients with perioperative high vs. low haemoglobin levels in relation to transfusion with blood products .</measure>
    <time_frame>Perioperative</time_frame>
    <description>High vs. low hb defined as 6,0 &lt; hb &gt; 6,0. Absolute PPI levels perioperative measured with a 5 minute interval. Blood transfusion measured as total amount used perioperatively.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Fracture of Hip</condition>
  <condition>Ileus</condition>
  <condition>Perforated Viscus</condition>
  <condition>Anastomotic Leak</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients &gt; 18 years of age having performed acute abdominal or orthopedic surgery from 1th&#xD;
        November 2017 through 31th October 2018 at Hvidovre and Bispebjerg University Hospitals.&#xD;
        Study subjects will be obtained from the hospitals electronic medical records via specific&#xD;
        procedural- or diagnostic codes representing the acute orthopedic or abdominal surgery in&#xD;
        the specified one-year period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Orthopedic surgery patients with fracture of the hip, booked in the electronic patient&#xD;
             record for operation with procedural codes:KNFB02 HNFJ81 KNFJ51 KNFJ52 KNFJ70&#xD;
&#xD;
          -  Acute abdominal surgery patients booked in the electronic patient record for operation&#xD;
             with procedural codes:KJAH01 KJAH00&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No sampling of PPI registered&#xD;
&#xD;
          -  Foreign/temporary civil registration number&#xD;
&#xD;
          -  Already included in cohort&#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>Department of Anesthesia, Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <state>Copenhagen</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Marianne Agerskov</investigator_full_name>
    <investigator_title>MD, Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anastomotic Leak</mesh_term>
    <mesh_term>Hip Fractures</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/NCT03795467
nct id: NCT03795467
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The peripheral perfusion index (PPI) is a non-invasive, feasible measure of peripheral
      perfusion and, assumed, the overall circulation, which all patients are monitored by.

      This study is carried out to assess the association between values of PPI, haemoglobin and
      blood transfusion.

      Hypothetically, patients with low values of hb are more susceptible to a deteriorating
      circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with
      blood products improves PPI measurements. Moreover, that patients with low values of PPI have
      more surgical complications and higher mortality.
Background: Acute surgical patients with e.g. hip fracture (HF) or acute abdominal surgical
      conditions often have comorbidities and a fragile circulation. Haemodynamic challenges make
      these patients vulnerable during anaesthesia, and perioperative complications are frequent.

      Anaemia is associated with increased mortality and adverse outcomes in patients undergoing
      surgery. One of the consequences of acute anaemia is reduced blood oxygen content, leading to
      reduced tissue oxygen delivery and development of tissue hypoxia. Patients with e.g. HF have
      a large drop in haemoglobin (hb) level that occurs after the injury, yet prior to the
      surgery. It is therefore important to be aware of the risk of preoperative anaemia even when
      the initial hb levels appear to be normal. Perioperative hb are associated with shorter
      lengths of hospital stay, reduced mortality and lower readmission rates, and patients with
      postoperative anaemia have increased mortality and length of hospital stay.

      Haemodynamic monitoring is traditionally based on measurement of blood pressure (BP) and
      heart rate (HR) but these measurements may be insufficient in evaluating overall oxygen
      delivery and perfusion of vital organs. An apparently sufficient BP and, for patients with
      more specialised monitoring, cardiac output (CO), does not necessarily mean a sufficient
      peripheral microcirculatory flow due to compensatory mechanisms, but on the other hand a low
      CO may be sufficient in context of low metabolic demand.

      The non-invasive peripheral perfusion index (PPI) is a numerical value of peripheral
      perfusion measured by the pulse oximeter derived from the photoelectric plethysmographic
      signal. PPI is represents the ratio between the pulsatile component (arterial) and the
      non-pulsatile component (venous blood, capillary blood and other tissues) of the light
      reaching the detector of the pulse oximeter, and reflects changes in peripheral blood flow as
      the pulsatile component increases with vasodilatation and decreases with vasoconstriction. It
      is an accessible way to obtain a measure for peripheral perfusion as pulse oximeters are
      universally available in all operating rooms and intensive care units. Previous studies have
      shown that PPI is a useful indicator of reduced peripheral blood flow both in clinical and
      experimental settings. Correlation between clinical symptoms of reduced peripheral perfusion
      such as low temperature, increased capillary response and reduced PPI in critically ill
      patients has been demonstrated, and a reduced peripheral perfusion may be a predictor of
      mortality and complications in patients undergoing major surgical procedures and in septic
      shock patients.

      Hypothetically, patients with low values of hb are more susceptible to a deteriorating
      circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with
      blood products improves PPI measurements. Moreover, that patients with low values of PPI have
      more surgical complications and higher mortality.

      Method: The main objective of this study is to estimate the association between perioperative
      values of PPI and haemoglobin levels. The secondary objectives are to evaluate PPI in
      patients with low hb in relation to mean arterial blood pressure (MAP), and evaluate changes
      in PPI with patients with low and normal hb in relation to transfusion with blood products.
observational model: Cohort
time perspective: Retrospective
measure: Peripheral perfusion index
time frame: Perioperative with 5 minute interval
description: Absolute PPI levels
measure: Haemoglobin level
time frame: Time interval: From 3 hours preoperative to 10 hours postoperative
description: Measurement of haemoglobin by blood sample or artery gas.
measure: Evaluation of Peripheral perfusion index in patients with high vs. low haemoglobin levels in relation to mean arterial blood pressure (MAP).
time frame: Perioperative
description: High vs. low hb defined as 6,0 < hb > 6,0. Absolute PPI levels perioperative with a 5 minute interval. Absolute values of MAP measured perioperative with a 5 minute interval.
measure: Proportion of transfusion with blood products in patients with perioperative high vs. low haemoglobin levels.
time frame: Perioperative
description: High vs. low hb defined as 6,0 < hb > 6,0. Blood transfusion measured as total amount used perioperatively.
measure: Evaluation of peripheral perfusion index changes in patients with perioperative high vs. low haemoglobin levels in relation to transfusion with blood products .
time frame: Perioperative
description: High vs. low hb defined as 6,0 < hb > 6,0. Absolute PPI levels perioperative measured with a 5 minute interval. Blood transfusion measured as total amount used perioperatively.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Marianne Agerskov
investigator title: MD, Research Fellow
mesh term: Anastomotic Leak
mesh term: Hip Fractures
sharing ipd: No