High Flow Nasal Cannula With Noninvasive Ventilation

Study Overview
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Brief Summary
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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
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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).

Official Title
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High Flow Nasal Cannula With Noninvasive Ventilation and Its Effect on High Risk Trauma Patients

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Other: Standard of Care - Nasal Cannula
* Other: High-flow nasal cannula
* Other: HFNC plus non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults at least 18 years of age Admission to an intensive care unit by the trauma surgery service Trauma patients receiving any respiratory therapies High risk patients, including intubation, post-operative, chronic cardiac or pulmonary comorbidities Thoracic injuries, including rib fractures, sternal fractures, spinal fractures, pulmonary contusions, pneumothorax, hemothorax, diaphragm injury Postoperative from thoracic surgery Postoperative from spine surgery in patients without spinal cord injury Abdominal injuries requiring open abdominal surgery No contraindications to using high flow nasal cannula or noninvasive ventilation Exclusion Criteria: Contraindication to using high flow nasal cannula or noninvasive ventilation Intolerance of pulmonary therapies No one able to give informed consent Long-term treatment with noninvasive ventilation prior to hospital admission Do not intubate order at time of extubation Unplanned extubation (accidental or self-extubation) Age < 18 years of age Traumatic brain injury with GCS < 8 Spinal cord injury Chronic neuromuscular disease Sinus precautions due to facial/sinus fractures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Not Intubated<br>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. | Other: Standard of Care - Nasal Cannula<br>* Standard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress.<br>Other: High-flow nasal cannula<br>* 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.<br>* Other names: HFNC;Other: HFNC plus non-invasive ventilation<br>* 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).<br>|
| Active Comparator: Intubated Patients Undergoing Extubation<br>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. | Other: Standard of Care - Nasal Cannula<br>* Standard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress.<br>Other: High-flow nasal cannula<br>* 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.<br>* Other names: HFNC;Other: HFNC plus non-invasive ventilation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rates-nonintubated patients | 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. | first 48 hours | 
| failure rates-intubated patients | 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. | first 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Assess mortality of enrolled patients by quarterly retrospective chart reviews. | Up to 2 years | 
| Length of hospital stay | Compare length of hospitalization between groups | up to 60 days | 
| Length of ICU stay | Compare length of ICU stay between groups | up to 30 days | 
| Discharge location | was patient discharged to home, rehabilitation facility, skilled nursing, death; compare between groups | up to 60 days | 
| Complications | Compare complications (such as need to be mechanically ventilated, infections, etc.) between groups | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute respiratory failure, mechanical ventilation