<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/NCT04463563</url>
  </required_header>
  <id_info>
    <org_study_id>REC-10/H0906/72</org_study_id>
    <nct_id>NCT04463563</nct_id>
  </id_info>
  <brief_title>Cerebral Oximetry in Cardiac Surgery to Reduce Neurological Impairment and Hospital Length-of-stay</brief_title>
  <official_title>Cerebral Oximetry in Adult Cardiac Surgery to Reduce the Incidence of Neurological Impairment and Hospital Length-of-stay: A Prospective, Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hull University Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hull and East Riding Cardiac Trust Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hull University Teaching Hospitals NHS 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cerebral oximetry using near-infrared spectroscopy (NIRS) has been shown to reduce the&#xD;
      incidence of neurological dysfunction and hospital length-of-stay in adult cardiac surgery&#xD;
      though not all studies agree. A previous audit using cerebral saturations at or above&#xD;
      baseline showed improved neurological and length-of-stay outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, single centre, double-blinded controlled study randomized 182 consecutive&#xD;
      patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass.&#xD;
      Participants were randomized by concealed envelope prior to anaesthesia. NIRS study group&#xD;
      were managed perioperatively using our NIRS protocol. The control group had standard&#xD;
      management without NIRS. Primary outcomes were post-operative neurological impairment and&#xD;
      hospital length-of-stay. Secondary outcomes included ventilation times, intensive care unit&#xD;
      length-of-stay, major organ dysfunction and mortality&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2011</start_date>
  <completion_date type="Actual">September 1, 2014</completion_date>
  <primary_completion_date type="Actual">March 1, 2014</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>
    <intervention_model_description>This prospective, single centre, double-blinded controlled study randomized 182 consecutive patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass. Participants were randomized by concealed envelope.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The personnel assessing and collecting the post-operative data were unaware of the patient group in the operating room.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital length-of-stay</measure>
    <time_frame>Measured in days from the day of operation to the day the patient is discharged from hospital or death in hospital. If neither has occurred within 6 months of participant's operation it will be recorded as 6 months hospital stay.</time_frame>
    <description>How long before discharge post-operatively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical neurological examination</measure>
    <time_frame>3 day post-operatively</time_frame>
    <description>Mobility and conscious control of limbs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurological assessment.</measure>
    <time_frame>6 months post-operatively</time_frame>
    <description>Telephone interview to assess patients perception of mobility, function and well being. (see below details)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive test 1</measure>
    <time_frame>Day 3 post op.</time_frame>
    <description>Fluency and cognitive functions: Mini-Mental State Examination (MMSE). This test is conducted as a questionnaire of 11 questions. Questions include 'what is the date?', 'name the town you are in?', spelling-forwards and backwards, counting backwards, copying a picture, follow an instruction, naming objects etc. The test is scored out of 30 and recorded in a table. The test is repeated on the third post op day and the 2 scores compared to give a number which relates to performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive Test 2</measure>
    <time_frame>Day 3 post op</time_frame>
    <description>Visual attention and task switching: Trail Making test A and B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive test 3</measure>
    <time_frame>Day 3 post op</time_frame>
    <description>Visual-spatial, frontal lobe: Anti-saccadic eye test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive test 4</measure>
    <time_frame>Day 3 post op</time_frame>
    <description>Executive function/verbal immediate and delayed recall: Hopkins Verbal and Hopkins Delay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive test 5</measure>
    <time_frame>Day 3 post op</time_frame>
    <description>General well-being HADS (hospital anxiety and depression score) A and D. HADS A -hospital anxiety and depression score relating to Anxiety. HADS D- hospital anxiety and depression score relating to Depression. Patients are asked a question and their response is scored from 0-3. There are 14 questions the score is recorded and compared with the score after the same questions on the 3rd post-op day. The result gives an indication of the patient's mental state and how it may have changed dur to the sugery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Late neurocognitive test 1.Telephone questionnaire using elements of the previously used questionnaires.</measure>
    <time_frame>6 months post op</time_frame>
    <description>General health questions were: how is your overall health, memory, mood, motor function?Designed to be shorter and not require any visual skills. The questions include the patients perception of whether they believe in each domain that their performance is the same, better or worse than before the surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Late neurocognitive test 2. Telephone questionnaire using elements of the previously used questionnaires.</measure>
    <time_frame>6 months post op</time_frame>
    <description>Cognition questions were: Date, repeat and recall, serial 7s, spell, recall. Designed to be shorter and not require any visual skills. The questions include the patients perception of whether they believe in each domain that their performance is the same, better or worse than before the surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Late neurocognitive test 3</measure>
    <time_frame>6 months post op</time_frame>
    <description>Functionality questions were: Stairs, driving, cleaning, dressing, eating/cooking.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensive Care length-of-stay</measure>
    <time_frame>The assessment period is every day on ICU until participant moved to ward. Or patient dies on ICU. Total assessment period 6 months.</time_frame>
    <description>Days on ICU. The time from the day of surgery to the discharge to the ward or death. assessed .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major organ dysfunction</measure>
    <time_frame>Before hospital discharge</time_frame>
    <description>Renal function is assessed measuring creatinine. Gastrointestinal function is assessed by the diagnosis of ileus or ischaemic bowel at laparotomy. Cardiac function is assessed by the requirement for inotropic support. Respiratory function is assessed by the requirement for ventilation. All these outcomes are have clinical relevance during the stay on ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Day of surgery to death. If the participant is discharged from hospital alive it is not a mortality. Assessed for 6 months from the day of surgery.</time_frame>
    <description>Death in hospital at any time following surgery. Death is considered a mortality.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Cardiac Surgery</condition>
  <condition>Neural Injury</condition>
  <condition>Cerebral Ischemia</condition>
  <arm_group>
    <arm_group_label>NIRS group. Brain oxygen saturations group.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A monitor by means of non-invasive stickers will display cerebral oximetry (brain oxygen saturations) throughout the heart surgery.This gives a direct reading of brain frontal lobe oxygen levels. The baseline is recorded before the patient goes to sleep (anaesthetised) and throughout the surgery and time on cardiopulmonary bypass if the brain oxygen levels fall below baseline then various physiological changes are made to restore oxygen to baseline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Patient Monitoring</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No cerebral monitoring. Standard patient monitoring according to normal practice at Castle Hill Hospital apply.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiological</intervention_name>
    <description>Changes to carbon dioxide, oxygen flow, cardiac output, blood pressure, haemoglobin, surgical surveillance, depth of anaesthesia, patient position.</description>
    <arm_group_label>NIRS group. Brain oxygen saturations group.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patient over 18&#xD;
        years age. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Emergency surgery. Cardiac surgery without cardiopulmonary bypass. Inability to perform&#xD;
        test.&#xD;
&#xD;
        Persistent neurological conditions:&#xD;
&#xD;
        Recent stroke. Dementia. Alzheimer's Disease Parkinson's Disease&#xD;
&#xD;
        -&#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>Sean R Bennett, MB Chb</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Anaesthetist Hull Hospital Trust</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</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/NCT04463563
org study id: REC-10/H0906/72
nct id: NCT04463563
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Cerebral oximetry using near-infrared spectroscopy (NIRS) has been shown to reduce the
      incidence of neurological dysfunction and hospital length-of-stay in adult cardiac surgery
      though not all studies agree. A previous audit using cerebral saturations at or above
      baseline showed improved neurological and length-of-stay outcomes.
This prospective, single centre, double-blinded controlled study randomized 182 consecutive
      patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass.
      Participants were randomized by concealed envelope prior to anaesthesia. NIRS study group
      were managed perioperatively using our NIRS protocol. The control group had standard
      management without NIRS. Primary outcomes were post-operative neurological impairment and
      hospital length-of-stay. Secondary outcomes included ventilation times, intensive care unit
      length-of-stay, major organ dysfunction and mortality
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This prospective, single centre, double-blinded controlled study randomized 182 consecutive patients, scheduled for cardiac surgical procedures using cardiopulmonary bypass. Participants were randomized by concealed envelope.
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: The personnel assessing and collecting the post-operative data were unaware of the patient group in the operating room.
measure: Hospital length-of-stay
time frame: Measured in days from the day of operation to the day the patient is discharged from hospital or death in hospital. If neither has occurred within 6 months of participant's operation it will be recorded as 6 months hospital stay.
description: How long before discharge post-operatively.
measure: Physical neurological examination
time frame: 3 day post-operatively
description: Mobility and conscious control of limbs.
measure: Neurological assessment.
time frame: 6 months post-operatively
description: Telephone interview to assess patients perception of mobility, function and well being. (see below details)
measure: Neurocognitive test 1
time frame: Day 3 post op.
description: Fluency and cognitive functions: Mini-Mental State Examination (MMSE). This test is conducted as a questionnaire of 11 questions. Questions include 'what is the date?', 'name the town you are in?', spelling-forwards and backwards, counting backwards, copying a picture, follow an instruction, naming objects etc. The test is scored out of 30 and recorded in a table. The test is repeated on the third post op day and the 2 scores compared to give a number which relates to performance.
measure: Neurocognitive Test 2
time frame: Day 3 post op
description: Visual attention and task switching: Trail Making test A and B
measure: Neurocognitive test 3
time frame: Day 3 post op
description: Visual-spatial, frontal lobe: Anti-saccadic eye test
measure: Neurocognitive test 4
time frame: Day 3 post op
description: Executive function/verbal immediate and delayed recall: Hopkins Verbal and Hopkins Delay.
measure: Neurocognitive test 5
time frame: Day 3 post op
description: General well-being HADS (hospital anxiety and depression score) A and D. HADS A -hospital anxiety and depression score relating to Anxiety. HADS D- hospital anxiety and depression score relating to Depression. Patients are asked a question and their response is scored from 0-3. There are 14 questions the score is recorded and compared with the score after the same questions on the 3rd post-op day. The result gives an indication of the patient's mental state and how it may have changed dur to the sugery.
measure: Late neurocognitive test 1.Telephone questionnaire using elements of the previously used questionnaires.
time frame: 6 months post op
description: General health questions were: how is your overall health, memory, mood, motor function?Designed to be shorter and not require any visual skills. The questions include the patients perception of whether they believe in each domain that their performance is the same, better or worse than before the surgery.
measure: Late neurocognitive test 2. Telephone questionnaire using elements of the previously used questionnaires.
time frame: 6 months post op
description: Cognition questions were: Date, repeat and recall, serial 7s, spell, recall. Designed to be shorter and not require any visual skills. The questions include the patients perception of whether they believe in each domain that their performance is the same, better or worse than before the surgery.
measure: Late neurocognitive test 3
time frame: 6 months post op
description: Functionality questions were: Stairs, driving, cleaning, dressing, eating/cooking.
measure: Intensive Care length-of-stay
time frame: The assessment period is every day on ICU until participant moved to ward. Or patient dies on ICU. Total assessment period 6 months.
description: Days on ICU. The time from the day of surgery to the discharge to the ward or death. assessed .
measure: Major organ dysfunction
time frame: Before hospital discharge
description: Renal function is assessed measuring creatinine. Gastrointestinal function is assessed by the diagnosis of ileus or ischaemic bowel at laparotomy. Cardiac function is assessed by the requirement for inotropic support. Respiratory function is assessed by the requirement for ventilation. All these outcomes are have clinical relevance during the stay on ICU.
measure: Mortality
time frame: Day of surgery to death. If the participant is discharged from hospital alive it is not a mortality. Assessed for 6 months from the day of surgery.
description: Death in hospital at any time following surgery. Death is considered a mortality.
arm group label: NIRS group. Brain oxygen saturations group.
arm group type: Active Comparator
description: A monitor by means of non-invasive stickers will display cerebral oximetry (brain oxygen saturations) throughout the heart surgery.This gives a direct reading of brain frontal lobe oxygen levels. The baseline is recorded before the patient goes to sleep (anaesthetised) and throughout the surgery and time on cardiopulmonary bypass if the brain oxygen levels fall below baseline then various physiological changes are made to restore oxygen to baseline.
arm group label: Standard Patient Monitoring
arm group type: No Intervention
description: No cerebral monitoring. Standard patient monitoring according to normal practice at Castle Hill Hospital apply.
intervention type: Other
intervention name: Physiological
description: Changes to carbon dioxide, oxygen flow, cardiac output, blood pressure, haemoglobin, surgical surveillance, depth of anaesthesia, patient position.
arm group label: NIRS group. Brain oxygen saturations group.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sean R Bennett, MB Chb
role: Principal Investigator
affiliation: Consultant Anaesthetist Hull Hospital Trust
responsible party type: Sponsor
mesh term: Brain Ischemia
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No