<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/NCT03031275</url>
  </required_header>
  <id_info>
    <org_study_id>2013/2258-31/1</org_study_id>
    <nct_id>NCT03031275</nct_id>
  </id_info>
  <brief_title>Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <brief_summary>
    <textblock>
      Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center&#xD;
      Karolinska.&#xD;
&#xD;
      Patients: adult survivors treated with ECMO for severe refractory respiratory failure at&#xD;
      least 5 years earlier.&#xD;
&#xD;
      Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary&#xD;
      function testing, exercise tolerance, quality of life and mood disorder screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All adult patients treated at the ECMO Center Karolinska between 1995 and July 2009 were&#xD;
      screened for eligibility in January 2014. Patients living abroad (including non-Swedish&#xD;
      citizens), patients treated for non-respiratory conditions, diseased patients and patients&#xD;
      with a known pre-ECMO mental handicap were excluded.&#xD;
&#xD;
      Eligible patients were contacted, and patients who agreed to participate gave their written&#xD;
      informed consent. All studied patients underwent the same study protocol during a day at the&#xD;
      hospital, including a clinical interview, MRI scan of the brain, HRCT scan of the thorax,&#xD;
      pulmonary function testing, neuropsychological examination, walking test, self assessment&#xD;
      questionnaires for quality of life, anxiety, depression and post-traumatic stress.&#xD;
&#xD;
      Patient charts were reviewed for relevant clinical information, including age, gender, ECMO&#xD;
      mode (venovenous or venoarterial), time in hospital, on ECMO, non-ECMO ICU and on mechanical&#xD;
      ventilation; preexisting diseases, blood gas values and ventilator settings before initiation&#xD;
      of ECMO treatment. Hand written clinical data from the patients´ charts from every hour with&#xD;
      ECMO treatment was reviewed for ventilator settings, lung volumes, mean arterial pressure,&#xD;
      hemoglobin, lactate and oxygenation parameters during an observation period, which was&#xD;
      defined as the first 10 days on ECMO (or the entire treatment period if shorter than 10&#xD;
      days). This information was added to a digital database for the purpose of this study.&#xD;
&#xD;
      At the time of ECMO treatment, arterial hemoglobin oxygen saturation was measured by&#xD;
      peripheral pulse oximetry from the right ear, finger or nose. Venous preoxygenator lactate&#xD;
      and venous saturation values were used as indicators of sufficient (lactate &lt; 2 mmol l-1 ,&#xD;
      SvO2 ≥ 70%) or insufficient tissue perfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>All investigators (radiologist, neuropsychologist, physiotherapist) were masked from all patient details other than the fact that they were treated with ECMO (ie did not know when the patient was treated, for what condition, if any side effects were seen and so on).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests</measure>
    <time_frame>5-17 years after treatment</time_frame>
    <description>Wechsler Adult Intelligence Scale, 4th ed, Rey Auditory Verbal Learning Test (learning trials 1 to 5 and delayed recall), immediate recall from the Rey Complex Figure and Logical Memory I and II from Wechsler Memory Scale, 3rd ed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal brain imaging assessed by magnetic resonance imaging</measure>
    <time_frame>5-17 years after treatment</time_frame>
    <description>Sagittal and axial T1- and T2-weighted images, and coronal T2-weighted and T2-weighted fluid attenuated inversion recovery (FLAIR) images. Slice thickness 4 mm. Presence of hypoxic or anoxic damage, infarctions, hemorrhages, and contusion damage were described.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Pulmonary function</measure>
    <time_frame>5-17 years after treatment</time_frame>
    <description>Static and dynamic spirometry. Measured results as % of the expected normal values were presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan</measure>
    <time_frame>5-17 years after treatment</time_frame>
    <description>Non-contrast spiral scan. A series for grading of pulmonary changes was reconstructed, using a high spatial resolution reconstruction algorithm with 1 mm-width, overlapping slices. Four patterns were mapped: reticular, ground-glass opacification, consolidation and decreased attenuation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire</measure>
    <time_frame>5-17 years after treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36</measure>
    <time_frame>5-17 years after treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire</measure>
    <time_frame>5-17 years after treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with signs of a reduced exercise tolerance</measure>
    <time_frame>5-17 years after treatment</time_frame>
    <description>6-minute walking test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale</measure>
    <time_frame>5-17 years after treatment</time_frame>
  </primary_outcome>
  <enrollment type="Actual">31</enrollment>
  <condition>Long Term Adverse Effects</condition>
  <condition>Pneumonia</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Sepsis</condition>
  <condition>Critical Illness</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Extracorporeal Circulation; Complications</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>High-resolution computed tomography</intervention_name>
    <description>HRCT of the thorax</description>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Magnetic resonance imaging</intervention_name>
    <description>MRI of the brain</description>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive testing</intervention_name>
    <description>Neuropsychological testing</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients treated with ECMO at the ECMO Center Karolinska 1995 - July 2009&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diseased patients&#xD;
&#xD;
          -  Patients living abroad (including non-Swedish citizens)&#xD;
&#xD;
          -  Patients treated for non-respiratory conditions&#xD;
&#xD;
          -  Patients with a known pre-ECMO mental handicap&#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>ECMO Center Karolinska</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 22, 2017</last_update_submitted>
  <last_update_submitted_qc>January 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Bernhard Holzgraefe</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>extracorporeal circulation</keyword>
  <keyword>critical care outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Long Term Adverse Effects</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/NCT03031275
org study id: 2013/2258-31/1
nct id: NCT03031275
lead sponsor: 
Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center
      Karolinska.

      Patients: adult survivors treated with ECMO for severe refractory respiratory failure at
      least 5 years earlier.

      Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary
      function testing, exercise tolerance, quality of life and mood disorder screening.
All adult patients treated at the ECMO Center Karolinska between 1995 and July 2009 were
      screened for eligibility in January 2014. Patients living abroad (including non-Swedish
      citizens), patients treated for non-respiratory conditions, diseased patients and patients
      with a known pre-ECMO mental handicap were excluded.

      Eligible patients were contacted, and patients who agreed to participate gave their written
      informed consent. All studied patients underwent the same study protocol during a day at the
      hospital, including a clinical interview, MRI scan of the brain, HRCT scan of the thorax,
      pulmonary function testing, neuropsychological examination, walking test, self assessment
      questionnaires for quality of life, anxiety, depression and post-traumatic stress.

      Patient charts were reviewed for relevant clinical information, including age, gender, ECMO
      mode (venovenous or venoarterial), time in hospital, on ECMO, non-ECMO ICU and on mechanical
      ventilation; preexisting diseases, blood gas values and ventilator settings before initiation
      of ECMO treatment. Hand written clinical data from the patients´ charts from every hour with
      ECMO treatment was reviewed for ventilator settings, lung volumes, mean arterial pressure,
      hemoglobin, lactate and oxygenation parameters during an observation period, which was
      defined as the first 10 days on ECMO (or the entire treatment period if shorter than 10
      days). This information was added to a digital database for the purpose of this study.

      At the time of ECMO treatment, arterial hemoglobin oxygen saturation was measured by
      peripheral pulse oximetry from the right ear, finger or nose. Venous preoxygenator lactate
      and venous saturation values were used as indicators of sufficient (lactate < 2 mmol l-1 ,
      SvO2 ≥ 70%) or insufficient tissue perfusion.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Investigator)
masking description: All investigators (radiologist, neuropsychologist, physiotherapist) were masked from all patient details other than the fact that they were treated with ECMO (ie did not know when the patient was treated, for what condition, if any side effects were seen and so on).
measure: Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests
time frame: 5-17 years after treatment
description: Wechsler Adult Intelligence Scale, 4th ed, Rey Auditory Verbal Learning Test (learning trials 1 to 5 and delayed recall), immediate recall from the Rey Complex Figure and Logical Memory I and II from Wechsler Memory Scale, 3rd ed.
measure: Number of participants with abnormal brain imaging assessed by magnetic resonance imaging
time frame: 5-17 years after treatment
description: Sagittal and axial T1- and T2-weighted images, and coronal T2-weighted and T2-weighted fluid attenuated inversion recovery (FLAIR) images. Slice thickness 4 mm. Presence of hypoxic or anoxic damage, infarctions, hemorrhages, and contusion damage were described.
measure: Number of Participants With Abnormal Pulmonary function
time frame: 5-17 years after treatment
description: Static and dynamic spirometry. Measured results as % of the expected normal values were presented.
measure: Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan
time frame: 5-17 years after treatment
description: Non-contrast spiral scan. A series for grading of pulmonary changes was reconstructed, using a high spatial resolution reconstruction algorithm with 1 mm-width, overlapping slices. Four patterns were mapped: reticular, ground-glass opacification, consolidation and decreased attenuation.
measure: Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire
time frame: 5-17 years after treatment
measure: Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36
time frame: 5-17 years after treatment
measure: Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire
time frame: 5-17 years after treatment
measure: Number of participants with signs of a reduced exercise tolerance
time frame: 5-17 years after treatment
description: 6-minute walking test
measure: Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale
time frame: 5-17 years after treatment
intervention type: Radiation
intervention name: High-resolution computed tomography
description: HRCT of the thorax
intervention type: Radiation
intervention name: Magnetic resonance imaging
description: MRI of the brain
intervention type: Behavioral
intervention name: Cognitive testing
description: Neuropsychological testing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Bernhard Holzgraefe
investigator title: MD, PhD
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Critical Illness
mesh term: Long Term Adverse Effects