<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/NCT04407468</url>
  </required_header>
  <id_info>
    <org_study_id>1178/SESEQ-HSGJR/08-05-20/UTI</org_study_id>
    <nct_id>NCT04407468</nct_id>
  </id_info>
  <brief_title>Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19</brief_title>
  <acronym>APRONOX</acronym>
  <official_title>Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19 (APRONOX)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General San Juan del Rio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Nacional de Cancerologia de Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital General San Juan del Rio</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 prone position strategy for patients with acute respiratory distress syndrome (ARDS) is&#xD;
      simple and cost-effective from the first description on its use in patients with acute&#xD;
      respiratory failure to improve hypoxemia. Different studies have investigated its safety and&#xD;
      efficacy in various clinical settings, demonstrating that its early use in combination with&#xD;
      non-invasive mechanical ventilation (NIV) or high-flow oxygen therapy can reduce intubation&#xD;
      rate and mortality in ARDS. In the Coronavirus disease 2019 (COVID-19) pandemic, high-value&#xD;
      medicine and resource optimization are critical.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus disease 2019 (COVID-19) is a pandemic that has significantly challenged health&#xD;
      systems worldwide. Due to the large number of infections around the world, the implementation&#xD;
      of strategies to reduce the number of intubations and the need for invasive mechanical&#xD;
      ventilation becomes important. In addition to the inability of the Mexican health system to&#xD;
      respond, patients under invasive ventilation have not had a favorable survival outcome. Up to&#xD;
      97% mortality has been reported in patients requiring intubation. The exact cause of this&#xD;
      poor prognosis is not yet known. Early recognition of hypoxemic patients could help with the&#xD;
      results. It seems reasonable in these patients to perform procedures to improve the clinical&#xD;
      respiratory picture before intubation in less severe cases due to the aforementioned. Prone&#xD;
      patient placement during invasive mechanical ventilation is a widespread practice in the&#xD;
      management of severe ARDS of other etiologies. Currently, few attempts have been made to&#xD;
      implement the prone position in patients who spontaneously ventilate with supplemental&#xD;
      oxygen, high-flow nasal cannulas, or noninvasive mechanical ventilation. Taking into account&#xD;
      that it is a procedure that does not require additional infrastructure within the services&#xD;
      and does not represent an additional cost for its implementation, it becomes a valuable tool&#xD;
      in the context of COVID-19 where intubation is associated with high mortality and in a&#xD;
      Additionally, there are mechanical ventilator deficits in most hospitals. This work has&#xD;
      feasibility to be carried out because it will be carried out in critical areas that have&#xD;
      equipment and trained personnel for it in the different shifts, in addition to having&#xD;
      patients diagnosed with COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">July 13, 2020</completion_date>
  <primary_completion_date type="Actual">July 13, 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>To analyze the relationship between the prone position and the need for orotracheal intubation.</measure>
    <time_frame>3 months</time_frame>
    <description>Relationship between awake prone position and the tracheal intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The impact of the prone position on the partial oxygen saturation / inspired oxygen fraction index (SaO2 / FiO2).</measure>
    <time_frame>3 months</time_frame>
    <description>See the relationship between the awake prone position and the SaO2/FiO2 INDEX</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Determine the free hours without the need for orotracheal intubation of patients in the prone position.</measure>
    <time_frame>3 months</time_frame>
    <description>Determine the free hours without the need for orotracheal intubation of patients in the prone position.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">827</enrollment>
  <condition>COVID</condition>
  <condition>ARDS</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>COVID</arm_group_label>
    <description>Patients with or without prone position</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prone position</intervention_name>
    <description>Position of the patient in which he is face down, for an improvement in oxygenation</description>
    <arm_group_label>COVID</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population Patients diagnosed with COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Patient records with the following characteristics:&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
          -  Patients of both genders&#xD;
&#xD;
          -  Patients diagnosed with COVID-19 infection&#xD;
&#xD;
          -  Patients admitted to hospital&#xD;
&#xD;
          -  Complete file&#xD;
&#xD;
        Non-inclusion criteria • Patients who do not decide to participate in the study&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        • Files not found.&#xD;
&#xD;
        Elimination criteria&#xD;
&#xD;
          -  Files with incomplete data&#xD;
&#xD;
          -  File with a voluntary discharge or transfer note.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Orlando R Perez Nieto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital General San Juan del Rio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Materno Celaya</name>
      <address>
        <city>Celaya</city>
        <state>Guanajuato</state>
        <zip>38096</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santo Tomas</name>
      <address>
        <city>Querétaro City</city>
        <state>Queretaro</state>
        <zip>76116</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General San Juan del Rio</name>
      <address>
        <city>Querétaro City</city>
        <state>Queretaro</state>
        <zip>76804</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISSSTE Hospital Regional Merida</name>
      <address>
        <city>Mérida</city>
        <state>Yucatan</state>
        <zip>97219</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Zona 48 San PEDRO Xalpa IMSS</name>
      <address>
        <city>Estado De México</city>
        <zip>02710</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Fernando Quiroz Gutierrez</name>
      <address>
        <city>Mexico City</city>
        <zip>01140</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Wan S, Li M, Ye Z, Yang C, Cai Q, Duan S, Song B. CT Manifestations and Clinical Characteristics of 1115 Patients with Coronavirus Disease 2019 (COVID-19): A Systematic Review and Meta-analysis. Acad Radiol. 2020 Jul;27(7):910-921. doi: 10.1016/j.acra.2020.04.033. Epub 2020 May 5.</citation>
    <PMID>32505599</PMID>
  </reference>
  <results_reference>
    <citation>Valter C, Christensen AM, Tollund C, Schonemann NK. Response to the prone position in spontaneously breathing patients with hypoxemic respiratory failure. Acta Anaesthesiol Scand. 2003 Apr;47(4):416-8. doi: 10.1034/j.1399-6576.2003.00088.x.</citation>
    <PMID>12694139</PMID>
  </results_reference>
  <results_reference>
    <citation>Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.</citation>
    <PMID>26271685</PMID>
  </results_reference>
  <results_reference>
    <citation>Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.</citation>
    <PMID>32000806</PMID>
  </results_reference>
  <results_reference>
    <citation>Perez-Nieto OR, Guerrero-Gutierrez MA, Deloya-Tomas E, Namendys-Silva SA. Prone positioning combined with high-flow nasal cannula in severe noninfectious ARDS. Crit Care. 2020 Mar 23;24(1):114. doi: 10.1186/s13054-020-2821-y. No abstract available.</citation>
    <PMID>32204726</PMID>
  </results_reference>
  <results_reference>
    <citation>Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available.</citation>
    <PMID>32189136</PMID>
  </results_reference>
  <results_reference>
    <citation>Caputo ND, Strayer RJ, Levitan R. Early Self-Proning in Awake, Non-intubated Patients in the Emergency Department: A Single ED's Experience During the COVID-19 Pandemic. Acad Emerg Med. 2020 May;27(5):375-378. doi: 10.1111/acem.13994.</citation>
    <PMID>32320506</PMID>
  </results_reference>
  <results_reference>
    <citation>Slessarev M, Cheng J, Ondrejicka M, Arntfield R; Critical Care Western Research Group. Patient self-proning with high-flow nasal cannula improves oxygenation in COVID-19 pneumonia. Can J Anaesth. 2020 Sep;67(9):1288-1290. doi: 10.1007/s12630-020-01661-0. Epub 2020 Apr 21. No abstract available.</citation>
    <PMID>32319029</PMID>
  </results_reference>
  <results_reference>
    <citation>Lomoro P, Verde F, Zerboni F, Simonetti I, Borghi C, Fachinetti C, Natalizi A, Martegani A. COVID-19 pneumonia manifestations at the admission on chest ultrasound, radiographs, and CT: single-center study and comprehensive radiologic literature review. Eur J Radiol Open. 2020;7:100231. doi: 10.1016/j.ejro.2020.100231. Epub 2020 Apr 4.</citation>
    <PMID>32289051</PMID>
  </results_reference>
  <results_reference>
    <citation>Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.</citation>
    <PMID>32101510</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General San Juan del Rio</investigator_affiliation>
    <investigator_full_name>Orlando Rubén Pérez-Nieto</investigator_full_name>
    <investigator_title>Dr. Orlando Ruben Perez Nieto</investigator_title>
  </responsible_party>
  <keyword>COVID</keyword>
  <keyword>ARDS</keyword>
  <keyword>PRONE POSITION</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</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>May 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT04407468/Prot_000.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/NCT04407468
org study id: 1178/SESEQ-HSGJR/08-05-20/UTI
nct id: NCT04407468
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prone position strategy for patients with acute respiratory distress syndrome (ARDS) is
      simple and cost-effective from the first description on its use in patients with acute
      respiratory failure to improve hypoxemia. Different studies have investigated its safety and
      efficacy in various clinical settings, demonstrating that its early use in combination with
      non-invasive mechanical ventilation (NIV) or high-flow oxygen therapy can reduce intubation
      rate and mortality in ARDS. In the Coronavirus disease 2019 (COVID-19) pandemic, high-value
      medicine and resource optimization are critical.
Coronavirus disease 2019 (COVID-19) is a pandemic that has significantly challenged health
      systems worldwide. Due to the large number of infections around the world, the implementation
      of strategies to reduce the number of intubations and the need for invasive mechanical
      ventilation becomes important. In addition to the inability of the Mexican health system to
      respond, patients under invasive ventilation have not had a favorable survival outcome. Up to
      97% mortality has been reported in patients requiring intubation. The exact cause of this
      poor prognosis is not yet known. Early recognition of hypoxemic patients could help with the
      results. It seems reasonable in these patients to perform procedures to improve the clinical
      respiratory picture before intubation in less severe cases due to the aforementioned. Prone
      patient placement during invasive mechanical ventilation is a widespread practice in the
      management of severe ARDS of other etiologies. Currently, few attempts have been made to
      implement the prone position in patients who spontaneously ventilate with supplemental
      oxygen, high-flow nasal cannulas, or noninvasive mechanical ventilation. Taking into account
      that it is a procedure that does not require additional infrastructure within the services
      and does not represent an additional cost for its implementation, it becomes a valuable tool
      in the context of COVID-19 where intubation is associated with high mortality and in a
      Additionally, there are mechanical ventilator deficits in most hospitals. This work has
      feasibility to be carried out because it will be carried out in critical areas that have
      equipment and trained personnel for it in the different shifts, in addition to having
      patients diagnosed with COVID-19.
observational model: Cohort
time perspective: Retrospective
measure: To analyze the relationship between the prone position and the need for orotracheal intubation.
time frame: 3 months
description: Relationship between awake prone position and the tracheal intubation
measure: The impact of the prone position on the partial oxygen saturation / inspired oxygen fraction index (SaO2 / FiO2).
time frame: 3 months
description: See the relationship between the awake prone position and the SaO2/FiO2 INDEX
measure: Determine the free hours without the need for orotracheal intubation of patients in the prone position.
time frame: 3 months
description: Determine the free hours without the need for orotracheal intubation of patients in the prone position.
arm group label: COVID
description: Patients with or without prone position
intervention type: Procedure
intervention name: Prone position
description: Position of the patient in which he is face down, for an improvement in oxygenation
arm group label: COVID
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Orlando R Perez Nieto, MD
role: Principal Investigator
affiliation: Hospital General San Juan del Rio
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Mexico
citation: Wan S, Li M, Ye Z, Yang C, Cai Q, Duan S, Song B. CT Manifestations and Clinical Characteristics of 1115 Patients with Coronavirus Disease 2019 (COVID-19): A Systematic Review and Meta-analysis. Acad Radiol. 2020 Jul;27(7):910-921. doi: 10.1016/j.acra.2020.04.033. Epub 2020 May 5.
PMID: 32505599
citation: Valter C, Christensen AM, Tollund C, Schonemann NK. Response to the prone position in spontaneously breathing patients with hypoxemic respiratory failure. Acta Anaesthesiol Scand. 2003 Apr;47(4):416-8. doi: 10.1034/j.1399-6576.2003.00088.x.
PMID: 12694139
citation: Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.
PMID: 26271685
citation: Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
PMID: 32000806
citation: Perez-Nieto OR, Guerrero-Gutierrez MA, Deloya-Tomas E, Namendys-Silva SA. Prone positioning combined with high-flow nasal cannula in severe noninfectious ARDS. Crit Care. 2020 Mar 23;24(1):114. doi: 10.1186/s13054-020-2821-y. No abstract available.
PMID: 32204726
citation: Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available.
PMID: 32189136
citation: Caputo ND, Strayer RJ, Levitan R. Early Self-Proning in Awake, Non-intubated Patients in the Emergency Department: A Single ED's Experience During the COVID-19 Pandemic. Acad Emerg Med. 2020 May;27(5):375-378. doi: 10.1111/acem.13994.
PMID: 32320506
citation: Slessarev M, Cheng J, Ondrejicka M, Arntfield R; Critical Care Western Research Group. Patient self-proning with high-flow nasal cannula improves oxygenation in COVID-19 pneumonia. Can J Anaesth. 2020 Sep;67(9):1288-1290. doi: 10.1007/s12630-020-01661-0. Epub 2020 Apr 21. No abstract available.
PMID: 32319029
citation: Lomoro P, Verde F, Zerboni F, Simonetti I, Borghi C, Fachinetti C, Natalizi A, Martegani A. COVID-19 pneumonia manifestations at the admission on chest ultrasound, radiographs, and CT: single-center study and comprehensive radiologic literature review. Eur J Radiol Open. 2020;7:100231. doi: 10.1016/j.ejro.2020.100231. Epub 2020 Apr 4.
PMID: 32289051
citation: Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.
PMID: 32101510
responsible party type: Principal Investigator
investigator affiliation: Hospital General San Juan del Rio
investigator full name: Orlando Rubén Pérez-Nieto
investigator title: Dr. Orlando Ruben Perez Nieto
mesh term: Pneumonia
sharing ipd: No
provided document: 