<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/NCT04507425</url>
  </required_header>
  <id_info>
    <org_study_id>12248</org_study_id>
    <nct_id>NCT04507425</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannula With Noninvasive Ventilation</brief_title>
  <official_title>High Flow Nasal Cannula With Noninvasive Ventilation and Its Effect on High Risk Trauma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</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>
      This is a prospective, randomized, unblinded trial of trauma patients in the ICU who are&#xD;
      identified as being at a high risk to develop acute respiratory failure.&#xD;
&#xD;
      We hope that this study will help the study team to identify how best to use a more&#xD;
      aggressive respiratory treatment strategy in a high risk trauma population (thoracic trauma&#xD;
      or trauma patients requiring thoracic surgery, spine surgery, or open abdominal procedures)&#xD;
      to try and decrease the need for intubation with mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients consented will be randomly assigned into one of three groups: nasal cannula&#xD;
      (control group, our current standard of care), high-flow nasal cannula, high-flow nasal&#xD;
      cannula plus noninvasive ventilation.&#xD;
&#xD;
      After obtaining consent, patient will be randomized to interventions 1:1:1 within each of two&#xD;
      groups: patients admitted to the ICU without being intubated OR intubated patients undergoing&#xD;
      an extubation.&#xD;
&#xD;
      Randomization will be managed through RedCap. After consent, the treating clinician will log&#xD;
      into RedCap to obtain the patient's treating assignment.&#xD;
&#xD;
      The primary outcome of interest is failure of conservative ventilation intervention in&#xD;
      prevention of initial intubation or prevention of reintubation.&#xD;
&#xD;
      A chart review of all enrolled patients will be done quarterly to assess morbidity,&#xD;
      mortality, and outcomes.&#xD;
&#xD;
      No placebo will be used as all qualifying patients will be placed on nasal cannula, high-flow&#xD;
      nasal cannula, or high-flow nasal cannula plus noninvasive ventilation. All other treatments&#xD;
      will be standard of care.&#xD;
&#xD;
      Participants in the study will continue until the patient is discharged from the trauma ICU.&#xD;
&#xD;
      The study will end when the last person enrolled has been discharged from the trauma ICU. If&#xD;
      patient's participation ends prematurely, available data will be entered into the database&#xD;
      and evaluated appropriately.&#xD;
&#xD;
      This study will take place at the OU Medical Center (OUMC) among patients admitted to the&#xD;
      Trauma Intensive Care Unit.&#xD;
&#xD;
      Consent for study enrollment will take place at OUMC during discussion with physician&#xD;
      providing trauma care and the patient, family member, or next of kin consenting for the&#xD;
      study.&#xD;
&#xD;
      The following data will be collected and recorded: Supplemental oxygen requirements,&#xD;
      Date/Time of arrival, Date/Time of Admission to ICU, Date/Time of intubation procedure,&#xD;
      Date/Time of extubation, Ventilator settings, Duration of intubation, Comorbidities, PaCO2&#xD;
      values, PaO2 values, Vital signs at arrival and at admission to ICU, Age,Gender, Weight,&#xD;
      Height, BMI, Traumatic injuries, Diagnosis, Past medical history/medical co-morbidities,&#xD;
      Glasgow coma scale, Oxygen saturation, Negative inspiratory force score, Rapid shallow&#xD;
      breathing index score, Pulmonary treatments, including an intolerance to therapy, Injury&#xD;
      Severity Score (ISS) and/or Abbreviated Injury Scale (AIS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</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>Participants will be randomized into 1 of 3 interventions: nasal cannula, high flow nasal cannula, and high flow nasal cannula plus noninvasive ventilation within each of two groups: patients admitted to ICU without being intubated OR intubated patients undergoing an extubation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>failure rates-nonintubated patients</measure>
    <time_frame>first 48 hours</time_frame>
    <description>Among injured patients admitted to the intensive care unit (ICU) without being intubated, do failure rates within the first 48 hours of ICU admission differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as escalation to intubation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>failure rates-intubated patients</measure>
    <time_frame>first 48 hours</time_frame>
    <description>Among injured patients arriving intubated or who undergo intervention after hospital arrival, do failure rates within the first 48 hours after extubation differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as requiring reintubation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Assess mortality of enrolled patients by quarterly retrospective chart reviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>up to 60 days</time_frame>
    <description>Compare length of hospitalization between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Compare length of ICU stay between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge location</measure>
    <time_frame>up to 60 days</time_frame>
    <description>was patient discharged to home, rehabilitation facility, skilled nursing, death; compare between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Compare complications (such as need to be mechanically ventilated, infections, etc.) between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1770</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Not Intubated</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients admitted with a trauma injury who do not need to be intubated to receive treatment. Intubated means putting a tube down your throat to keep your airway from collapsing. Participants will be randomized to receive one of the three interventions in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intubated Patients Undergoing Extubation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients admitted with a trauma injury who had to be intubated for treatment of their injury. Interventions administered after the tube is extubated (removed from throat). Participants will be randomized to receive one of the three interventions in this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care - Nasal Cannula</intervention_name>
    <description>Standard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress.</description>
    <arm_group_label>Intubated Patients Undergoing Extubation</arm_group_label>
    <arm_group_label>Not Intubated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-flow nasal cannula</intervention_name>
    <description>Same as nasal cannula, except the oxygen is heated or humidified and the flow is stronger, pushing air into the lungs to help keep the airway open.</description>
    <arm_group_label>Intubated Patients Undergoing Extubation</arm_group_label>
    <arm_group_label>Not Intubated</arm_group_label>
    <other_name>HFNC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HFNC plus non-invasive ventilation</intervention_name>
    <description>This method uses HFNC as described above and adds noninvasive ventilation which is similar to CPAP machine and uses a mask rather than having to intubate (putting a tube down your throat to keep your airway from collapsing).</description>
    <arm_group_label>Intubated Patients Undergoing Extubation</arm_group_label>
    <arm_group_label>Not Intubated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults at least 18 years of age&#xD;
&#xD;
          2. Admission to an intensive care unit by the trauma surgery service&#xD;
&#xD;
          3. Trauma patients receiving any respiratory therapies&#xD;
&#xD;
          4. High risk patients, including intubation, post-operative, chronic cardiac or pulmonary&#xD;
             comorbidities&#xD;
&#xD;
          5. Thoracic injuries, including rib fractures, sternal fractures, spinal fractures,&#xD;
             pulmonary contusions, pneumothorax, hemothorax, diaphragm injury&#xD;
&#xD;
          6. Postoperative from thoracic surgery&#xD;
&#xD;
          7. Postoperative from spine surgery in patients without spinal cord injury&#xD;
&#xD;
          8. Abdominal injuries requiring open abdominal surgery&#xD;
&#xD;
          9. No contraindications to using high flow nasal cannula or noninvasive ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to using high flow nasal cannula or noninvasive ventilation&#xD;
&#xD;
          2. Intolerance of pulmonary therapies&#xD;
&#xD;
          3. No one able to give informed consent&#xD;
&#xD;
          4. Long-term treatment with noninvasive ventilation prior to hospital admission&#xD;
&#xD;
          5. &quot;Do not intubate&quot; order at time of extubation&#xD;
&#xD;
          6. Unplanned extubation (accidental or self-extubation)&#xD;
&#xD;
          7. Age &lt; 18 years of age&#xD;
&#xD;
          8. Traumatic brain injury with GCS &lt; 8&#xD;
&#xD;
          9. Spinal cord injury&#xD;
&#xD;
         10. Chronic neuromuscular disease&#xD;
&#xD;
         11. Sinus precautions due to facial/sinus fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celia Y Quang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Theresa Lander</last_name>
    <phone>405-271-2601</phone>
    <phone_ext>2</phone_ext>
    <email>theresa-lander@ouhsc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Asaleigh Cline</last_name>
    <phone>405-271-8001</phone>
    <phone_ext>56021</phone_ext>
    <email>asaleigh-cline@ouhsc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>OU Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Celia Quang, MD</last_name>
      <phone>405-271-8001</phone>
      <phone_ext>55004</phone_ext>
      <email>celia-quang@ouhsc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>OU Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theresa Lander</last_name>
      <phone>405-271-2601</phone>
      <phone_ext>43230</phone_ext>
      <email>theresa-lander@ouhsc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Stephanie Mitchell, RN</last_name>
      <phone>405-271-2128</phone>
      <email>Stephanie-mitchell@ouhsc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Thille AW, Boissier F, Ben-Ghezala H, Razazi K, Mekontso-Dessap A, Brun-Buisson C, Brochard L. Easily identified at-risk patients for extubation failure may benefit from noninvasive ventilation: a prospective before-after study. Crit Care. 2016 Feb 26;20:48. doi: 10.1186/s13054-016-1228-2.</citation>
    <PMID>26926168</PMID>
  </results_reference>
  <results_reference>
    <citation>Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901. Erratum In: JAMA. 2020 Feb 25;323(8):793.</citation>
    <PMID>31577036</PMID>
  </results_reference>
  <results_reference>
    <citation>Xu Z, Li Y, Zhou J, Li X, Huang Y, Liu X, Burns KEA, Zhong N, Zhang H. High-flow nasal cannula in adults with acute respiratory failure and after extubation: a systematic review and meta-analysis. Respir Res. 2018 Oct 16;19(1):202. doi: 10.1186/s12931-018-0908-7.</citation>
    <PMID>30326893</PMID>
  </results_reference>
  <results_reference>
    <citation>Honrubia T, Garcia Lopez FJ, Franco N, Mas M, Guevara M, Daguerre M, Alia I, Algora A, Galdos P. Noninvasive vs conventional mechanical ventilation in acute respiratory failure: a multicenter, randomized controlled trial. Chest. 2005 Dec;128(6):3916-24. doi: 10.1378/chest.128.6.3916.</citation>
    <PMID>16354864</PMID>
  </results_reference>
  <results_reference>
    <citation>Halub ME, Spilman SK, Gaunt KA, Lamb KD, Jackson JA, Oetting TW, Sahr SM. High-flow nasal cannula therapy for patients with blunt thoracic injury: A retrospective study. Can J Respir Ther. 2016 Fall;52(4):110-113. Epub 2016 Nov 1.</citation>
    <PMID>30996619</PMID>
  </results_reference>
  <results_reference>
    <citation>Gaunt KA, Spilman SK, Halub ME, Jackson JA, Lamb KD, Sahr SM. High-Flow Nasal Cannula in a Mixed Adult ICU. Respir Care. 2015 Oct;60(10):1383-9. doi: 10.4187/respcare.04016. Epub 2015 Jun 9.</citation>
    <PMID>26060320</PMID>
  </results_reference>
  <results_reference>
    <citation>Lamb KD, Spilman SK, Oetting TW, Jackson JA, Trump MW, Sahr SM. Proactive Use of High-Flow Nasal Cannula With Critically Ill Subjects. Respir Care. 2018 Mar;63(3):259-266. doi: 10.4187/respcare.05793. Epub 2017 Dec 5.</citation>
    <PMID>29208754</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute respiratory failure</keyword>
  <keyword>mechanical ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT04507425
org study id: 12248
nct id: NCT04507425
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized, unblinded trial of trauma patients in the ICU who are
      identified as being at a high risk to develop acute respiratory failure.

      We hope that this study will help the study team to identify how best to use a more
      aggressive respiratory treatment strategy in a high risk trauma population (thoracic trauma
      or trauma patients requiring thoracic surgery, spine surgery, or open abdominal procedures)
      to try and decrease the need for intubation with mechanical ventilation.
All patients consented will be randomly assigned into one of three groups: nasal cannula
      (control group, our current standard of care), high-flow nasal cannula, high-flow nasal
      cannula plus noninvasive ventilation.

      After obtaining consent, patient will be randomized to interventions 1:1:1 within each of two
      groups: patients admitted to the ICU without being intubated OR intubated patients undergoing
      an extubation.

      Randomization will be managed through RedCap. After consent, the treating clinician will log
      into RedCap to obtain the patient's treating assignment.

      The primary outcome of interest is failure of conservative ventilation intervention in
      prevention of initial intubation or prevention of reintubation.

      A chart review of all enrolled patients will be done quarterly to assess morbidity,
      mortality, and outcomes.

      No placebo will be used as all qualifying patients will be placed on nasal cannula, high-flow
      nasal cannula, or high-flow nasal cannula plus noninvasive ventilation. All other treatments
      will be standard of care.

      Participants in the study will continue until the patient is discharged from the trauma ICU.

      The study will end when the last person enrolled has been discharged from the trauma ICU. If
      patient's participation ends prematurely, available data will be entered into the database
      and evaluated appropriately.

      This study will take place at the OU Medical Center (OUMC) among patients admitted to the
      Trauma Intensive Care Unit.

      Consent for study enrollment will take place at OUMC during discussion with physician
      providing trauma care and the patient, family member, or next of kin consenting for the
      study.

      The following data will be collected and recorded: Supplemental oxygen requirements,
      Date/Time of arrival, Date/Time of Admission to ICU, Date/Time of intubation procedure,
      Date/Time of extubation, Ventilator settings, Duration of intubation, Comorbidities, PaCO2
      values, PaO2 values, Vital signs at arrival and at admission to ICU, Age,Gender, Weight,
      Height, BMI, Traumatic injuries, Diagnosis, Past medical history/medical co-morbidities,
      Glasgow coma scale, Oxygen saturation, Negative inspiratory force score, Rapid shallow
      breathing index score, Pulmonary treatments, including an intolerance to therapy, Injury
      Severity Score (ISS) and/or Abbreviated Injury Scale (AIS).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized into 1 of 3 interventions: nasal cannula, high flow nasal cannula, and high flow nasal cannula plus noninvasive ventilation within each of two groups: patients admitted to ICU without being intubated OR intubated patients undergoing an extubation.
primary purpose: Treatment
masking: None (Open Label)
measure: failure rates-nonintubated patients
time frame: first 48 hours
description: Among injured patients admitted to the intensive care unit (ICU) without being intubated, do failure rates within the first 48 hours of ICU admission differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as escalation to intubation.
measure: failure rates-intubated patients
time frame: first 48 hours
description: Among injured patients arriving intubated or who undergo intervention after hospital arrival, do failure rates within the first 48 hours after extubation differ with respect to type of initial respiratory intervention: nasal cannula, high-flow nasal cannula (HFNC), or HFNC plus non-invasive ventilation (BiPAP). Failure is defined as requiring reintubation.
measure: Mortality
time frame: Up to 2 years
description: Assess mortality of enrolled patients by quarterly retrospective chart reviews.
measure: Length of hospital stay
time frame: up to 60 days
description: Compare length of hospitalization between groups
measure: Length of ICU stay
time frame: up to 30 days
description: Compare length of ICU stay between groups
measure: Discharge location
time frame: up to 60 days
description: was patient discharged to home, rehabilitation facility, skilled nursing, death; compare between groups
measure: Complications
time frame: up to 2 years
description: Compare complications (such as need to be mechanically ventilated, infections, etc.) between groups
arm group label: Not Intubated
arm group type: Active Comparator
description: Patients admitted with a trauma injury who do not need to be intubated to receive treatment. Intubated means putting a tube down your throat to keep your airway from collapsing. Participants will be randomized to receive one of the three interventions in this arm.
arm group label: Intubated Patients Undergoing Extubation
arm group type: Active Comparator
description: Patients admitted with a trauma injury who had to be intubated for treatment of their injury. Interventions administered after the tube is extubated (removed from throat). Participants will be randomized to receive one of the three interventions in this arm.
intervention type: Other
intervention name: Standard of Care - Nasal Cannula
description: Standard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress.
arm group label: Intubated Patients Undergoing Extubation
arm group label: Not Intubated
intervention type: Other
intervention name: High-flow nasal cannula
description: Same as nasal cannula, except the oxygen is heated or humidified and the flow is stronger, pushing air into the lungs to help keep the airway open.
arm group label: Intubated Patients Undergoing Extubation
arm group label: Not Intubated
other name: HFNC
intervention type: Other
intervention name: HFNC plus non-invasive ventilation
description: This method uses HFNC as described above and adds noninvasive ventilation which is similar to CPAP machine and uses a mask rather than having to intubate (putting a tube down your throat to keep your airway from collapsing).
arm group label: Intubated Patients Undergoing Extubation
arm group label: Not Intubated
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Celia Y Quang, MD
role: Principal Investigator
affiliation: University of Oklahoma
last name: Theresa Lander
phone: 405-271-2601
phone ext: 2
email: theresa-lander@ouhsc.edu
last name: Asaleigh Cline
phone: 405-271-8001
phone ext: 56021
email: asaleigh-cline@ouhsc.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Thille AW, Boissier F, Ben-Ghezala H, Razazi K, Mekontso-Dessap A, Brun-Buisson C, Brochard L. Easily identified at-risk patients for extubation failure may benefit from noninvasive ventilation: a prospective before-after study. Crit Care. 2016 Feb 26;20:48. doi: 10.1186/s13054-016-1228-2.
PMID: 26926168
citation: Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901. Erratum In: JAMA. 2020 Feb 25;323(8):793.
PMID: 31577036
citation: Xu Z, Li Y, Zhou J, Li X, Huang Y, Liu X, Burns KEA, Zhong N, Zhang H. High-flow nasal cannula in adults with acute respiratory failure and after extubation: a systematic review and meta-analysis. Respir Res. 2018 Oct 16;19(1):202. doi: 10.1186/s12931-018-0908-7.
PMID: 30326893
citation: Honrubia T, Garcia Lopez FJ, Franco N, Mas M, Guevara M, Daguerre M, Alia I, Algora A, Galdos P. Noninvasive vs conventional mechanical ventilation in acute respiratory failure: a multicenter, randomized controlled trial. Chest. 2005 Dec;128(6):3916-24. doi: 10.1378/chest.128.6.3916.
PMID: 16354864
citation: Halub ME, Spilman SK, Gaunt KA, Lamb KD, Jackson JA, Oetting TW, Sahr SM. High-flow nasal cannula therapy for patients with blunt thoracic injury: A retrospective study. Can J Respir Ther. 2016 Fall;52(4):110-113. Epub 2016 Nov 1.
PMID: 30996619
citation: Gaunt KA, Spilman SK, Halub ME, Jackson JA, Lamb KD, Sahr SM. High-Flow Nasal Cannula in a Mixed Adult ICU. Respir Care. 2015 Oct;60(10):1383-9. doi: 10.4187/respcare.04016. Epub 2015 Jun 9.
PMID: 26060320
citation: Lamb KD, Spilman SK, Oetting TW, Jackson JA, Trump MW, Sahr SM. Proactive Use of High-Flow Nasal Cannula With Critically Ill Subjects. Respir Care. 2018 Mar;63(3):259-266. doi: 10.4187/respcare.05793. Epub 2017 Dec 5.
PMID: 29208754
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
sharing ipd: No