<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/NCT04424836</url>
  </required_header>
  <id_info>
    <org_study_id>5569</org_study_id>
    <nct_id>NCT04424836</nct_id>
  </id_info>
  <brief_title>HFNC Treatment in COVID-19 Pneumonia</brief_title>
  <official_title>the Effect of HFNC Treatment on Mortality and Length of ICU Stay in Patient With COVID-19 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>
      coronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is&#xD;
      the most common reason for ICU admission. We have several different way for respiratory&#xD;
      support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the&#xD;
      effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the first group (group H), the data of patients undergoing HFNC treatment, and in group II&#xD;
      (Group K), the data of patients who received COT with a reservoir mask were included.&#xD;
&#xD;
      In HFNC support, the current air temperature is 31-37 degrees, the flow rate is 30-60 lt /&#xD;
      min, and the FiO2 value is targeted so that saturation is 93% and above. Initially,&#xD;
      continuous treatment was applied intermittently after the partial oxygen pressure / fraction&#xD;
      of inspired oxygen(fio2) ratio exceeded 250 and clinical well-being occurred.&#xD;
&#xD;
      In patients in Group K, fingertip saturation was targeted as 93% and above, and a COT was&#xD;
      applied with a reservoir mask with a flow rate of 6-15 l / min.&#xD;
&#xD;
      The flow rate was calculated using the formula of FiO2 (%) = 21 + 4 * (liters / min) in&#xD;
      patients undergoing COT. Noninvasive mechanical ventilation was applied to patients who could&#xD;
      not be provided with adequate clinical and laboratory well-being in both groups (partial&#xD;
      oxygen pressure / fraction of inspired oxygen ratio below 150) and invasive mechanical&#xD;
      ventilation if this was insufficient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">June 5, 2020</completion_date>
  <primary_completion_date type="Actual">June 4, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>short term mortality</measure>
    <time_frame>in 28 days.</time_frame>
    <description>the mortality rate of patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>icu stay</measure>
    <time_frame>up to 28 days</time_frame>
    <description>means the stay day of patients in intensive care unit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood gases</measure>
    <time_frame>at the admission time and 24th hour</time_frame>
    <description>partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Pneumonia, Viral</condition>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>H GROUP</arm_group_label>
    <description>patients get the oxygen supply with high flow nasal cannula . In group H, HFNC device settings the initial flow rate was 30 L/min and could be increased to 60. The Fio2 was adjusted to maintain oxygen saturation as indicated by a pulse oximetry reading of grater than or equal to %90.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C GROUP</arm_group_label>
    <description>patients get the oxygen supply with conventional methods. In group C 6-15 L/min oxygen delivered to patients by conventional methods and targeted to maintain the oxygen saturation %90 or over.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>high flow nasal cannula device</intervention_name>
    <description>device is supplying oxygen with heated and humidified air in a high flow rate</description>
    <arm_group_label>H GROUP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        coronavirus disease 2019 patients admitted to the ICU for acute respiratory failure 15&#xD;
        march to 15 may&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  We include the patient with acute respiratory failure related coronavirus disease 2019&#xD;
             (diagnosed with polymerase Chain Reaction), older than 18 year and supported by High&#xD;
             Flow Nasal cannulae or conventional oxygen treatment(COT).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with primary pulmonary disease, Glasgow Coma scale≤ 12 , respiratory acidosis&#xD;
             in the first blood gases(ph≤ 7,2 - pCO2≥50) will exclude.&#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>ayse su cinar</last_name>
    <role>Study Chair</role>
  </overall_official>
  <location>
    <facility>
      <name>Sisli Etfal Research and Training Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34371</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum In: JAMA. 2021 May 25;325(20):2120.</citation>
    <PMID>32250385</PMID>
  </results_reference>
  <results_reference>
    <citation>Arabi YM, Arifi AA, Balkhy HH, Najm H, Aldawood AS, Ghabashi A, Hawa H, Alothman A, Khaldi A, Al Raiy B. Clinical course and outcomes of critically ill patients with Middle East respiratory syndrome coronavirus infection. Ann Intern Med. 2014 Mar 18;160(6):389-97. doi: 10.7326/M13-2486.</citation>
    <PMID>24474051</PMID>
  </results_reference>
  <results_reference>
    <citation>Akerstrom S, Gunalan V, Keng CT, Tan YJ, Mirazimi A. Dual effect of nitric oxide on SARS-CoV replication: viral RNA production and palmitoylation of the S protein are affected. Virology. 2009 Dec 5;395(1):1-9. doi: 10.1016/j.virol.2009.09.007. Epub 2009 Oct 1.</citation>
    <PMID>19800091</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 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>specialist medical doctor</investigator_title>
  </responsible_party>
  <keyword>high flow nasal cannula (HFNC)</keyword>
  <keyword>conventional oxygen treatment (COT)</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>Pneumonia, Viral</mesh_term>
    <mesh_term>Respiratory Insufficiency</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 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT04424836/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 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT04424836/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/NCT04424836
org study id: 5569
nct id: NCT04424836
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
coronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is
      the most common reason for ICU admission. We have several different way for respiratory
      support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the
      effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.
In the first group (group H), the data of patients undergoing HFNC treatment, and in group II
      (Group K), the data of patients who received COT with a reservoir mask were included.

      In HFNC support, the current air temperature is 31-37 degrees, the flow rate is 30-60 lt /
      min, and the FiO2 value is targeted so that saturation is 93% and above. Initially,
      continuous treatment was applied intermittently after the partial oxygen pressure / fraction
      of inspired oxygen(fio2) ratio exceeded 250 and clinical well-being occurred.

      In patients in Group K, fingertip saturation was targeted as 93% and above, and a COT was
      applied with a reservoir mask with a flow rate of 6-15 l / min.

      The flow rate was calculated using the formula of FiO2 (%) = 21 + 4 * (liters / min) in
      patients undergoing COT. Noninvasive mechanical ventilation was applied to patients who could
      not be provided with adequate clinical and laboratory well-being in both groups (partial
      oxygen pressure / fraction of inspired oxygen ratio below 150) and invasive mechanical
      ventilation if this was insufficient.
observational model: Case-Control
time perspective: Retrospective
measure: short term mortality
time frame: in 28 days.
description: the mortality rate of patients
measure: icu stay
time frame: up to 28 days
description: means the stay day of patients in intensive care unit
measure: blood gases
time frame: at the admission time and 24th hour
description: partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg
arm group label: H GROUP
description: patients get the oxygen supply with high flow nasal cannula . In group H, HFNC device settings the initial flow rate was 30 L/min and could be increased to 60. The Fio2 was adjusted to maintain oxygen saturation as indicated by a pulse oximetry reading of grater than or equal to %90.
arm group label: C GROUP
description: patients get the oxygen supply with conventional methods. In group C 6-15 L/min oxygen delivered to patients by conventional methods and targeted to maintain the oxygen saturation %90 or over.
intervention type: Device
intervention name: high flow nasal cannula device
description: device is supplying oxygen with heated and humidified air in a high flow rate
arm group label: H GROUP
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: ayse su cinar
role: Study Chair
facility: 
country: Turkey
citation: Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum In: JAMA. 2021 May 25;325(20):2120.
PMID: 32250385
citation: Arabi YM, Arifi AA, Balkhy HH, Najm H, Aldawood AS, Ghabashi A, Hawa H, Alothman A, Khaldi A, Al Raiy B. Clinical course and outcomes of critically ill patients with Middle East respiratory syndrome coronavirus infection. Ann Intern Med. 2014 Mar 18;160(6):389-97. doi: 10.7326/M13-2486.
PMID: 24474051
citation: Akerstrom S, Gunalan V, Keng CT, Tan YJ, Mirazimi A. Dual effect of nitric oxide on SARS-CoV replication: viral RNA production and palmitoylation of the S protein are affected. Virology. 2009 Dec 5;395(1):1-9. doi: 10.1016/j.virol.2009.09.007. Epub 2009 Oct 1.
PMID: 19800091
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Mustafa Altınay
investigator title: specialist medical doctor
mesh term: Pneumonia
mesh term: Coronavirus Infections
mesh term: Pneumonia, Viral
mesh term: Respiratory Insufficiency
sharing ipd: No
provided document: 
provided document: 