<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/NCT03281993</url>
  </required_header>
  <id_info>
    <org_study_id>KB-0012/116/13</org_study_id>
    <nct_id>NCT03281993</nct_id>
  </id_info>
  <brief_title>Apnea Tests as the Methods of Brain Death Diagnosis.</brief_title>
  <acronym>DiagBD</acronym>
  <official_title>Alternative Apnea Test as the Method of Brain Death Diagnosis .</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pomeranian Medical University Szczecin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pomeranian Medical University Szczecin</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Apnea test (AT) is the most important clinical test performed usually at the end of brain&#xD;
      death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be&#xD;
      completed in patients with extremely compromised lung function due to rapid blood&#xD;
      desaturation and circulatory disturbances. Therefore the investigators decided to verify&#xD;
      alternative AT options such as continuous positive airway pressure apnea test (CPAP-AT) in&#xD;
      patients with good and poor baseline oxygenation, before implementing them in currently&#xD;
      reviewed Polish BD criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Apnea test (AT) is one of the most important examination during the diagnosis of brain death.&#xD;
      It is usually performed at the end of each series of clinical examinations during diagnostic&#xD;
      process. The most popular standard insufflation apnea test (I-AT) may be potentially harmful.&#xD;
      It may cause some serious complications including pneumothorax, severe hypoxemia, hemodynamic&#xD;
      instability and even cardiac arrest. Therefore, the investigators decided to analyze apnea&#xD;
      test in CPAP option (CPAP-AT) as a new tool. For safety of the study the investigators&#xD;
      analyzed a method after BD diagnosis.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      I-AT and hypoventilation with 100 % oxygen (if needed) were performed according to Polish&#xD;
      guidelines. Two hours after BD diagnosis was performed extra apnea test in CPAP option&#xD;
      (CPAP-AT). Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator&#xD;
      settings were changed to CPAP mode with PEEP 10 cm H2O, PS 0 cm H2O, FiO2 1,0, flow 6L/min.&#xD;
      Emergency apnea ventilation was turned off. At the beginning of CPAP mode and 10 minutes&#xD;
      after, blood samples for arterial blood gases (ABG) were collected. If were observed rapid&#xD;
      desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborted and study&#xD;
      was finished.&#xD;
&#xD;
      During routine diagnosis of brain death, pupillary dilation after a neck flexion was observed&#xD;
      in one case. Therefore, the investigators decided to use a pupillometer during brain death&#xD;
      examination to find out how pupils react after a neck flexion and how often it happens.&#xD;
&#xD;
      Pupil measurements were taken immediately after the diagnosis of brain death. The&#xD;
      measurements of pupil diameter were taken twice: A - before neck flexion; B - after neck&#xD;
      flexion. We used pupillometer: AlgiScan (Equip Medkey BV).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2015</start_date>
  <completion_date type="Actual">June 25, 2017</completion_date>
  <primary_completion_date type="Actual">June 25, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline arterial blood gases (ABG) during CPAP-AT</measure>
    <time_frame>10 minutes</time_frame>
    <description>After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator parameters were modified to: 0 H2O of pressure support (PS), 10 cm H2O of PEEP, 6l/min of O2 flow and 0.2 l/min of sensitivity. Before the test and 10 minutes after then was taken blood probe to ABG and type of ventilation change to pretest settings. The test is considered valid if there is no respiratory activity despite the rise of PaCO2 above 60mmHg and over 20mmHg above the baseline. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">76</enrollment>
  <condition>Brain Death</condition>
  <condition>Apnea</condition>
  <condition>Pupillary Anomaly</condition>
  <arm_group>
    <arm_group_label>CPAP-AT</arm_group_label>
    <description>After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT and 10 minutes after blood samples for arterial blood gases (ABG) were collected. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CPAP AT</intervention_name>
    <description>If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%; the CPAP apnea test (CPAP-AT) test was aborted.</description>
    <arm_group_label>CPAP-AT</arm_group_label>
    <other_name>change type of ventylation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Intubated adult ICU patients at the Intensive Care Unit of the Department of Anaesthesia&#xD;
        and Intensive Care teaching hospital at the Pomeranian Medical University in Szczecin&#xD;
        during Brain Death diagnosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  brain death diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no&#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>Joanna Pastuszka, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pomeranian Medical University</affiliation>
  </overall_official>
  <reference>
    <citation>Solek-Pastuszka J, Sawicki M, Iwanczuk W, Bohatyrewicz R. Ventilator-Delivered Continuous Positive Airway Pressure for Apnea Test in the Diagnosis of Brain Death in Patient With Extremely Poor Baseline Lung Function-Case Report. Transplant Proc. 2016 Sep;48(7):2471-2472. doi: 10.1016/j.transproceed.2016.02.089.</citation>
    <PMID>27742325</PMID>
  </reference>
  <reference>
    <citation>Saucha W, Solek-Pastuszka J, Bohatyrewicz R, Knapik P. Apnea test in the determination of brain death in patients treated with extracorporeal membrane oxygenation (ECMO). Anaesthesiol Intensive Ther. 2015;47(4):368-71. doi: 10.5603/AIT.2015.0051.</citation>
    <PMID>26401745</PMID>
  </reference>
  <reference>
    <citation>Solek-Pastuszka J, Saucha W, Iwanczuk W, Bohatyrewicz R. Evolution of apnoea test in brain death diagnostics. Anaesthesiol Intensive Ther. 2015;47(4):363-7. doi: 10.5603/AIT.2015.0050.</citation>
    <PMID>26401744</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pomeranian Medical University Szczecin</investigator_affiliation>
    <investigator_full_name>Joanna Sołek-Pastuszka</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>apnea test, brain death, pupillometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Brain Death</mesh_term>
    <mesh_term>Pupil Disorders</mesh_term>
    <mesh_term>Death</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/NCT03281993
org study id: KB-0012/116/13
nct id: NCT03281993
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Apnea test (AT) is the most important clinical test performed usually at the end of brain
      death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be
      completed in patients with extremely compromised lung function due to rapid blood
      desaturation and circulatory disturbances. Therefore the investigators decided to verify
      alternative AT options such as continuous positive airway pressure apnea test (CPAP-AT) in
      patients with good and poor baseline oxygenation, before implementing them in currently
      reviewed Polish BD criteria.
Apnea test (AT) is one of the most important examination during the diagnosis of brain death.
      It is usually performed at the end of each series of clinical examinations during diagnostic
      process. The most popular standard insufflation apnea test (I-AT) may be potentially harmful.
      It may cause some serious complications including pneumothorax, severe hypoxemia, hemodynamic
      instability and even cardiac arrest. Therefore, the investigators decided to analyze apnea
      test in CPAP option (CPAP-AT) as a new tool. For safety of the study the investigators
      analyzed a method after BD diagnosis.

      Methods:

      I-AT and hypoventilation with 100 % oxygen (if needed) were performed according to Polish
      guidelines. Two hours after BD diagnosis was performed extra apnea test in CPAP option
      (CPAP-AT). Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator
      settings were changed to CPAP mode with PEEP 10 cm H2O, PS 0 cm H2O, FiO2 1,0, flow 6L/min.
      Emergency apnea ventilation was turned off. At the beginning of CPAP mode and 10 minutes
      after, blood samples for arterial blood gases (ABG) were collected. If were observed rapid
      desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborted and study
      was finished.

      During routine diagnosis of brain death, pupillary dilation after a neck flexion was observed
      in one case. Therefore, the investigators decided to use a pupillometer during brain death
      examination to find out how pupils react after a neck flexion and how often it happens.

      Pupil measurements were taken immediately after the diagnosis of brain death. The
      measurements of pupil diameter were taken twice: A - before neck flexion; B - after neck
      flexion. We used pupillometer: AlgiScan (Equip Medkey BV).
observational model: Other
time perspective: Prospective
measure: Change from baseline arterial blood gases (ABG) during CPAP-AT
time frame: 10 minutes
description: After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator parameters were modified to: 0 H2O of pressure support (PS), 10 cm H2O of PEEP, 6l/min of O2 flow and 0.2 l/min of sensitivity. Before the test and 10 minutes after then was taken blood probe to ABG and type of ventilation change to pretest settings. The test is considered valid if there is no respiratory activity despite the rise of PaCO2 above 60mmHg and over 20mmHg above the baseline. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd.
arm group label: CPAP-AT
description: After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT and 10 minutes after blood samples for arterial blood gases (ABG) were collected. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd.
intervention type: Other
intervention name: CPAP AT
description: If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%; the CPAP apnea test (CPAP-AT) test was aborted.
arm group label: CPAP-AT
other name: change type of ventylation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanna Pastuszka, MD PhD
role: Principal Investigator
affiliation: Pomeranian Medical University
citation: Solek-Pastuszka J, Sawicki M, Iwanczuk W, Bohatyrewicz R. Ventilator-Delivered Continuous Positive Airway Pressure for Apnea Test in the Diagnosis of Brain Death in Patient With Extremely Poor Baseline Lung Function-Case Report. Transplant Proc. 2016 Sep;48(7):2471-2472. doi: 10.1016/j.transproceed.2016.02.089.
PMID: 27742325
citation: Saucha W, Solek-Pastuszka J, Bohatyrewicz R, Knapik P. Apnea test in the determination of brain death in patients treated with extracorporeal membrane oxygenation (ECMO). Anaesthesiol Intensive Ther. 2015;47(4):368-71. doi: 10.5603/AIT.2015.0051.
PMID: 26401745
citation: Solek-Pastuszka J, Saucha W, Iwanczuk W, Bohatyrewicz R. Evolution of apnoea test in brain death diagnostics. Anaesthesiol Intensive Ther. 2015;47(4):363-7. doi: 10.5603/AIT.2015.0050.
PMID: 26401744
responsible party type: Principal Investigator
investigator affiliation: Pomeranian Medical University Szczecin
investigator full name: Joanna Sołek-Pastuszka
investigator title: MD PhD
mesh term: Apnea
mesh term: Brain Death
mesh term: Pupil Disorders
mesh term: Death
sharing ipd: No