<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/NCT04427969</url>
  </required_header>
  <id_info>
    <org_study_id>pp34</org_study_id>
    <nct_id>NCT04427969</nct_id>
  </id_info>
  <brief_title>Early Prone Position on Coronavirus Disease 2019 Pneumonia</brief_title>
  <acronym>Prone Position</acronym>
  <official_title>The Effect of Early Prone Position on Prognosis in Acute Respiratory Failure Due to Coronavirus Disease 2019 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research 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 purpose of this study to evaluate the effect of early awake PP (prone&#xD;
      position)application on oxygenation and intubation requirement in patients with acute&#xD;
      respiratory failure due to coronavirus disease 2019 pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first group (early prone position-EPP) created for our study was composed of patients who&#xD;
      received PP at least 12 hours early (with the first 48 hours) with the oxygen support of the&#xD;
      reservoir mask, and the second group (non-EPP ) patients who received oxygen with the&#xD;
      reservoir mask but could not be applied early PP due to the patient's incompatibility or&#xD;
      rejection.&#xD;
&#xD;
      Conventional oxygen therapy applied to all patients was given with a reservoir mask, aiming&#xD;
      at oxygen saturation 93% and above, at a flow rate of 6-15 L / min.&#xD;
&#xD;
      Despite all the treatments, the patients who have a follow-up with a respiratory acidosis ,&#xD;
      oxygen saturation value below 93%, applied non invasive mechanical ventilation, in case of&#xD;
      insufficient patient intubated and have invasive mechanical ventilation. In patients who had&#xD;
      regression of glasgow coma scale during follow-up, orotracheal intubation was performed and&#xD;
      invasive mechanical ventilation was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2020</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>intensive care unit stay</measure>
    <time_frame>up to 28 days</time_frame>
    <description>the duration of icu stay day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>short term mortality</measure>
    <time_frame>up to 28 days</time_frame>
    <description>mortality percent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood gases</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">33</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>EPP</arm_group_label>
    <description>patients who applied early awake prone position for treatment with conventional oxygen supply</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-EPP</arm_group_label>
    <description>patient who only get conventional oxygen therapy as respiratory supply</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>prone position</intervention_name>
    <description>to lay in prone position at least 12 hour in a day at ICU</description>
    <arm_group_label>EPP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The data of patients over 18 years old who were followed up and treated in the intensive&#xD;
        care unit due to acute respiratory failure due to coronavirus disease 2019 pneumonia were&#xD;
        retrospectively reviewed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who developed acute respiratory failure due to coronavirus disease 2019&#xD;
             pneumonia&#xD;
&#xD;
          -  received conventional oxygen therapy with reservoir mask oxygen at the stage of&#xD;
             admission to the intensive care unit&#xD;
&#xD;
          -  older than 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with respiratory acidosis,&#xD;
&#xD;
          -  partial oxygen pressure/fraction of inspired oxygen ratio below 150,&#xD;
&#xD;
          -  Glasgow Coma Score (GKS) below 12 points,&#xD;
&#xD;
          -  hemodynamic instability,&#xD;
&#xD;
          -  primary pulmonary pathologies other than pneumonia (lung cancer, cardiopulmonary&#xD;
             edema, carcinogen syndrome, etc.)&#xD;
&#xD;
          -  patients who underwent non-invasive mechanical ventilation(NIMV) or intubated from&#xD;
             admission to intensive care,&#xD;
&#xD;
          -  those who underwent self prone position under 12 hours were not included in the study.&#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>ayse surhan cinar</last_name>
    <role>Study Chair</role>
    <affiliation>chief of anesthesia department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sisli Etfal Research and Training Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Marmara</state>
        <zip>34400</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.</citation>
    <PMID>32007143</PMID>
  </results_reference>
  <results_reference>
    <citation>Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.</citation>
    <PMID>23688302</PMID>
  </results_reference>
  <results_reference>
    <citation>Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.</citation>
    <PMID>26493592</PMID>
  </results_reference>
  <results_reference>
    <citation>Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.</citation>
    <PMID>29068269</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>November 7, 2020</last_update_submitted>
  <last_update_submitted_qc>November 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Mustafa Altınay</investigator_full_name>
    <investigator_title>spercialist medical doctor</investigator_title>
  </responsible_party>
  <keyword>coronavirus disease 2019</keyword>
  <keyword>prone position</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT04427969/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT04427969/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04427969
org study id: pp34
nct id: NCT04427969
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the purpose of this study to evaluate the effect of early awake PP (prone
      position)application on oxygenation and intubation requirement in patients with acute
      respiratory failure due to coronavirus disease 2019 pneumonia.
The first group (early prone position-EPP) created for our study was composed of patients who
      received PP at least 12 hours early (with the first 48 hours) with the oxygen support of the
      reservoir mask, and the second group (non-EPP ) patients who received oxygen with the
      reservoir mask but could not be applied early PP due to the patient's incompatibility or
      rejection.

      Conventional oxygen therapy applied to all patients was given with a reservoir mask, aiming
      at oxygen saturation 93% and above, at a flow rate of 6-15 L / min.

      Despite all the treatments, the patients who have a follow-up with a respiratory acidosis ,
      oxygen saturation value below 93%, applied non invasive mechanical ventilation, in case of
      insufficient patient intubated and have invasive mechanical ventilation. In patients who had
      regression of glasgow coma scale during follow-up, orotracheal intubation was performed and
      invasive mechanical ventilation was performed.
observational model: Cohort
time perspective: Retrospective
measure: intensive care unit stay
time frame: up to 28 days
description: the duration of icu stay day
measure: short term mortality
time frame: up to 28 days
description: mortality percent
measure: blood gases
time frame: up to 24 hours
description: partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg
arm group label: EPP
description: patients who applied early awake prone position for treatment with conventional oxygen supply
arm group label: non-EPP
description: patient who only get conventional oxygen therapy as respiratory supply
intervention type: Behavioral
intervention name: prone position
description: to lay in prone position at least 12 hour in a day at ICU
arm group label: EPP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ayse surhan cinar
role: Study Chair
affiliation: chief of anesthesia department
facility: 
country: Turkey
citation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PMID: 32007143
citation: Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
PMID: 23688302
citation: Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.
PMID: 26493592
citation: Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.
PMID: 29068269
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Mustafa Altınay
investigator title: spercialist medical doctor
mesh term: Pneumonia
mesh term: Coronavirus Infections
mesh term: COVID-19
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome
sharing ipd: No
provided document: 
provided document: 