<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/NCT03818841</url>
  </required_header>
  <id_info>
    <org_study_id>CO-HFNC</org_study_id>
    <nct_id>NCT03818841</nct_id>
  </id_info>
  <brief_title>The Role of High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning</brief_title>
  <official_title>High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi del Piemonte Orientale &quot;Amedeo Avogadro&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi del Piemonte Orientale &quot;Amedeo Avogadro&quot;</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>
      The aim of the study is to test whether oxygen therapy delivered through high-flow nasal&#xD;
      cannula devices in patients admitted to the emergency department for acute carbon monoxide&#xD;
      poisoning is superior to the non-rebreathing oxygen face mask therapy with a 15 L/minute&#xD;
      oxygen flow (currently the first-line therapy), in terms of reduction of carboxyhemoglobin&#xD;
      (COHb) concentration and delayed neurological sequelae incidence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomised controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COHb reduction at 90 minutes</measure>
    <time_frame>90 minutes</time_frame>
    <description>Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of COHb reduction at 90 minutes. The hypothesis is that in patients treated with high flow nasal cannula the reduction in COHb at 90 minutes will be significantly different compared to patients treated with non-rebreathing oxygen mask.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation in the incidence of delayed neurologic sequelae</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of incidence and severity of delayed neurologic syndrome.&#xD;
At the time of discharge from the emergency department, each enrolled patient will undergo neurocognitive testing.&#xD;
Six weeks after discharge, a follow-up visit for each patient will be performed which will include neurocognitive testing and a functional magnetic resonance imaging, in order to determine the presence of delayed neurologic sequelae.&#xD;
Patients in the two groups of treatment will be subsequently compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in serum lactate concentration</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of serum lactate variations. In particular, serum lactate levels will be evaluated at different time points, in order to test whether different treatments lead to different kinetic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in serum troponin concentration</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of troponin concentration variations. In particular, serum troponin levels will be evaluated at different time points, in order to test whether different treatments lead to different kinetic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in S100B levels concentration</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of serum protein S100B variations. In particular, protein S100B will be evaluated at different time points, in order to test whether different treatments lead to different protein kinetic.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Carbon Monoxide Poisoning</condition>
  <arm_group>
    <arm_group_label>High-flow nasal cannula group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomised in this group will receive oxygen therapy via a high-flow nasal cannula device with a 60 L/min flow and a 100% fraction of inspired oxygen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-rebreathing oxygen mask group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this group patients will be treated with standard oxygen therapy delivered through a non-rebreathing face mask with a 15 L/min flow</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-flow nasal cannula device</intervention_name>
    <description>Patients will be randomly allocated to this treatment</description>
    <arm_group_label>High-flow nasal cannula group</arm_group_label>
    <other_name>AIRVO 2, Fisher &amp; Paykel Healthcare LTD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-rebreathing oxygen mask group</intervention_name>
    <description>Patients will be randomly allocated to this treatment</description>
    <arm_group_label>Non-rebreathing oxygen mask group</arm_group_label>
    <other_name>Standard non-rebreathing oxygen mask</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age v 18 years&#xD;
&#xD;
          -  Carbon monoxide intoxication as major problem leading to emergency department&#xD;
             admission&#xD;
&#xD;
          -  Carboxyhemoglobin (COHb) concentration 10% at the time of enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Glasgow coma scale ≤ 13&#xD;
&#xD;
          -  Refusal to give consent&#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>Luigi M Castello, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>A.O.U. Maggiore della Carità di Novara</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luigi M Castello, MD</last_name>
    <phone>+3903213733097</phone>
    <email>luigi.castello@med.uniupo.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francesco Gavelli, MD</last_name>
    <email>francesco.gavelli@uniupo.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AOU Maggiore della Carità di Novara. Emergency Medicine Department. Department of Translational Medicine.</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luigi M Castello, MD</last_name>
      <phone>+3903213733097</phone>
      <email>luigi.castello@med.uniupo.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.</citation>
    <PMID>25558703</PMID>
  </results_reference>
  <results_reference>
    <citation>Jeon SB, Sohn CH, Seo DW, Oh BJ, Lim KS, Kang DW, Kim WY. Acute Brain Lesions on Magnetic Resonance Imaging and Delayed Neurological Sequelae in Carbon Monoxide Poisoning. JAMA Neurol. 2018 Apr 1;75(4):436-443. doi: 10.1001/jamaneurol.2017.4618.</citation>
    <PMID>29379952</PMID>
  </results_reference>
  <results_reference>
    <citation>Rose JJ, Wang L, Xu Q, McTiernan CF, Shiva S, Tejero J, Gladwin MT. Carbon Monoxide Poisoning: Pathogenesis, Management, and Future Directions of Therapy. Am J Respir Crit Care Med. 2017 Mar 1;195(5):596-606. doi: 10.1164/rccm.201606-1275CI. Erratum In: Am J Respir Crit Care Med. 2017 Aug 1;196 (3):398-399.</citation>
    <PMID>27753502</PMID>
  </results_reference>
  <results_reference>
    <citation>Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.</citation>
    <PMID>25866645</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
    <mesh_term>Carbon Monoxide Poisoning</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/NCT03818841
org study id: CO-HFNC
nct id: NCT03818841
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to test whether oxygen therapy delivered through high-flow nasal
      cannula devices in patients admitted to the emergency department for acute carbon monoxide
      poisoning is superior to the non-rebreathing oxygen face mask therapy with a 15 L/minute
      oxygen flow (currently the first-line therapy), in terms of reduction of carboxyhemoglobin
      (COHb) concentration and delayed neurological sequelae incidence.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: COHb reduction at 90 minutes
time frame: 90 minutes
description: Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of COHb reduction at 90 minutes. The hypothesis is that in patients treated with high flow nasal cannula the reduction in COHb at 90 minutes will be significantly different compared to patients treated with non-rebreathing oxygen mask.
measure: Variation in the incidence of delayed neurologic sequelae
time frame: 6 weeks
description: Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of incidence and severity of delayed neurologic syndrome.
At the time of discharge from the emergency department, each enrolled patient will undergo neurocognitive testing.
Six weeks after discharge, a follow-up visit for each patient will be performed which will include neurocognitive testing and a functional magnetic resonance imaging, in order to determine the presence of delayed neurologic sequelae.
Patients in the two groups of treatment will be subsequently compared.
measure: Variation in serum lactate concentration
time frame: 6 weeks
description: Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of serum lactate variations. In particular, serum lactate levels will be evaluated at different time points, in order to test whether different treatments lead to different kinetic.
measure: Variation in serum troponin concentration
time frame: 6 weeks
description: Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of troponin concentration variations. In particular, serum troponin levels will be evaluated at different time points, in order to test whether different treatments lead to different kinetic.
measure: Variation in S100B levels concentration
time frame: 6 weeks
description: Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of serum protein S100B variations. In particular, protein S100B will be evaluated at different time points, in order to test whether different treatments lead to different protein kinetic.
arm group label: High-flow nasal cannula group
arm group type: Experimental
description: Patients randomised in this group will receive oxygen therapy via a high-flow nasal cannula device with a 60 L/min flow and a 100% fraction of inspired oxygen
arm group label: Non-rebreathing oxygen mask group
arm group type: Other
description: In this group patients will be treated with standard oxygen therapy delivered through a non-rebreathing face mask with a 15 L/min flow
intervention type: Device
intervention name: High-flow nasal cannula device
description: Patients will be randomly allocated to this treatment
arm group label: High-flow nasal cannula group
other name: AIRVO 2, Fisher & Paykel Healthcare LTD
intervention type: Device
intervention name: Non-rebreathing oxygen mask group
description: Patients will be randomly allocated to this treatment
arm group label: Non-rebreathing oxygen mask group
other name: Standard non-rebreathing oxygen mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luigi M Castello, MD
role: Principal Investigator
affiliation: A.O.U. Maggiore della Carità di Novara
last name: Luigi M Castello, MD
phone: +3903213733097
email: luigi.castello@med.uniupo.it
last name: Francesco Gavelli, MD
email: francesco.gavelli@uniupo.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.
PMID: 25558703
citation: Jeon SB, Sohn CH, Seo DW, Oh BJ, Lim KS, Kang DW, Kim WY. Acute Brain Lesions on Magnetic Resonance Imaging and Delayed Neurological Sequelae in Carbon Monoxide Poisoning. JAMA Neurol. 2018 Apr 1;75(4):436-443. doi: 10.1001/jamaneurol.2017.4618.
PMID: 29379952
citation: Rose JJ, Wang L, Xu Q, McTiernan CF, Shiva S, Tejero J, Gladwin MT. Carbon Monoxide Poisoning: Pathogenesis, Management, and Future Directions of Therapy. Am J Respir Crit Care Med. 2017 Mar 1;195(5):596-606. doi: 10.1164/rccm.201606-1275CI. Erratum In: Am J Respir Crit Care Med. 2017 Aug 1;196 (3):398-399.
PMID: 27753502
citation: Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
PMID: 25866645
responsible party type: Sponsor
mesh term: Poisoning
mesh term: Carbon Monoxide Poisoning
sharing ipd: No