High Flow Nasal Cannula With Noninvasive Ventilation
Condition: Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Standard of Care - Nasal Cannula; High-flow nasal cannula; HFNC plus non-invasive ventilation
Intervention type(s): Other; Other; Other
Intervention description(s): Standard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress.; 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.; 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).
Other intervention name(s): HFNC
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute respiratory failure; mechanical ventilation