<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/NCT02998749</url>
  </required_header>
  <id_info>
    <org_study_id>Gasping1</org_study_id>
    <nct_id>NCT02998749</nct_id>
  </id_info>
  <brief_title>Gasping Improves Long-term Survival After Out-of-hospital Cardiac Arrest</brief_title>
  <official_title>Agonal Breathing is a Positive Predictive Factor of Long Term Survival After Out-of-hospital Cardiac Arrest</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charles University, Czech Republic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our retrospective clinical study was to examine the association between agonal&#xD;
      breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim&#xD;
      was to examine role of basic life support (BLS) and response time. Our hypothesis is that&#xD;
      agonal breathing has positive effects on both primary and secondary endpoints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims Agonal breathing (&quot;gasping for air&quot;) has previously been found to be associated with the&#xD;
      outcomes of out-of-hospital cardiac arrest (OHCA) patients on which resuscitation was&#xD;
      attempted. On the other hand, little is known, about agonal breathing with regard to whether&#xD;
      it is a positive factor for survival after hospital admission and how it relates to the&#xD;
      patient's future quality of life. For this reason we have undertaken a retrospective study&#xD;
      using a comprehensive emergency medical service (EMS) database from the Central Bohemian&#xD;
      region of the Czech Republic. The primary endpoint of the study was to assess if agonal&#xD;
      breathing present when EMS arrives has a positive impact on the six-month survival of OHCA&#xD;
      patients, which was independent of other factors like EMS response time and BLS provision.&#xD;
      The secondary endpoints sought to determine if agonal breathing positively impacts ROSC and&#xD;
      an evaluation of various factors that can influence agonal breathing, specifically response&#xD;
      time and provision of BLS.&#xD;
&#xD;
      Method The data were recorded using the Utstein protocol. Only anonymized data were used for&#xD;
      analysis. The data were derived from the EMS registry of the Central Bohemian Region, which&#xD;
      is the largest EMS in the Czech Republic. The study sample included all OHCA cases, of&#xD;
      presumed cardiac origin, that where resuscitated by the EMS between 1st July 2013 and 30th&#xD;
      June 2014 (n = 584). Two subsequent patient outcomes: (1) return of spontaneous circulation&#xD;
      (defined as spontaneous circulation at hospital admission) and (2) six-month survival were&#xD;
      assessed in patients with and without agonal breathing. Six-month survival data of OHCA&#xD;
      patients of presumed cardiac origin was derived from administrative insurance registries or&#xD;
      medical records of patients, with only aggregated data being available.&#xD;
&#xD;
      Factors that may influence the presence of agonal breathing, specifically BLS provision&#xD;
      before a professional EMS team reached the patient and second, EMS team response times, were&#xD;
      also examined. BLS provision by lay persons was reported by the first-on-scene EMS team as&#xD;
      (yes/no) and phone assisted CPR was registered by the dispatcher as (yes/no). BLS was&#xD;
      considered to have been provided if any of the following activities (1) resuscitation by a&#xD;
      bystander, (2) phone assisted CPR, or (3) both were recorded as having been performed. The&#xD;
      response time was calculated as the elapsed time between recorded activation of an EMS team&#xD;
      and the on scene arrival time.&#xD;
&#xD;
      Other covariates such as age and sex were also available and analyzed. The initial difference&#xD;
      in response time between the groups was assessed using the T-test. For categorical variables,&#xD;
      the chi-square test was used. Simple and multivariate logistic regression models were used to&#xD;
      assess relationships between factors related to the presence of agonal breathing and ROSC. A&#xD;
      p-value of &lt; 0.05 was considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>association between agonal breathing and long-term survival</measure>
    <time_frame>6 months after successful resuscitation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>impact of agonal breathing on return of spontaneous circulation</measure>
    <time_frame>immediately after resuscitation</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">584</enrollment>
  <condition>Cardiac Arrest With Successful Resuscitation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Victims of primary out-of-hospital cardiac arrest&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: all out-of-hospital cardiac arrest cases, of presumed cardiac origin,&#xD;
        that where resuscitated by the emergency medical service of Central Bohemia region between&#xD;
        1st July 2013 and 30th June 2014 (n = 584) -&#xD;
&#xD;
        Exclusion Criteria: other than non-cardiac cause of cardiac arrest&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Jiri Malek</investigator_full_name>
    <investigator_title>Assoc. Prof.. MD, Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</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/NCT02998749
org study id: Gasping1
nct id: NCT02998749
lead sponsor: 
has dmc: No
The aim of our retrospective clinical study was to examine the association between agonal
      breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim
      was to examine role of basic life support (BLS) and response time. Our hypothesis is that
      agonal breathing has positive effects on both primary and secondary endpoints.
Aims Agonal breathing ("gasping for air") has previously been found to be associated with the
      outcomes of out-of-hospital cardiac arrest (OHCA) patients on which resuscitation was
      attempted. On the other hand, little is known, about agonal breathing with regard to whether
      it is a positive factor for survival after hospital admission and how it relates to the
      patient's future quality of life. For this reason we have undertaken a retrospective study
      using a comprehensive emergency medical service (EMS) database from the Central Bohemian
      region of the Czech Republic. The primary endpoint of the study was to assess if agonal
      breathing present when EMS arrives has a positive impact on the six-month survival of OHCA
      patients, which was independent of other factors like EMS response time and BLS provision.
      The secondary endpoints sought to determine if agonal breathing positively impacts ROSC and
      an evaluation of various factors that can influence agonal breathing, specifically response
      time and provision of BLS.

      Method The data were recorded using the Utstein protocol. Only anonymized data were used for
      analysis. The data were derived from the EMS registry of the Central Bohemian Region, which
      is the largest EMS in the Czech Republic. The study sample included all OHCA cases, of
      presumed cardiac origin, that where resuscitated by the EMS between 1st July 2013 and 30th
      June 2014 (n = 584). Two subsequent patient outcomes: (1) return of spontaneous circulation
      (defined as spontaneous circulation at hospital admission) and (2) six-month survival were
      assessed in patients with and without agonal breathing. Six-month survival data of OHCA
      patients of presumed cardiac origin was derived from administrative insurance registries or
      medical records of patients, with only aggregated data being available.

      Factors that may influence the presence of agonal breathing, specifically BLS provision
      before a professional EMS team reached the patient and second, EMS team response times, were
      also examined. BLS provision by lay persons was reported by the first-on-scene EMS team as
      (yes/no) and phone assisted CPR was registered by the dispatcher as (yes/no). BLS was
      considered to have been provided if any of the following activities (1) resuscitation by a
      bystander, (2) phone assisted CPR, or (3) both were recorded as having been performed. The
      response time was calculated as the elapsed time between recorded activation of an EMS team
      and the on scene arrival time.

      Other covariates such as age and sex were also available and analyzed. The initial difference
      in response time between the groups was assessed using the T-test. For categorical variables,
      the chi-square test was used. Simple and multivariate logistic regression models were used to
      assess relationships between factors related to the presence of agonal breathing and ROSC. A
      p-value of < 0.05 was considered statistically significant.
observational model: Case-Control
time perspective: Prospective
measure: association between agonal breathing and long-term survival
time frame: 6 months after successful resuscitation
measure: impact of agonal breathing on return of spontaneous circulation
time frame: immediately after resuscitation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Jiri Malek
investigator title: Assoc. Prof.. MD, Ph.D.
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: No