High Flow Nasal Cannula With Noninvasive Ventilation and Its Effect on High Risk Trauma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- failure rates-nonintubated patients
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
failure rates-nonintubated patients
Time Frame: first 48 hours
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.
failure rates-intubated patients
Time Frame: first 48 hours
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.
Secondary Outcomes
- Discharge location(up to 60 days)
- Complications(up to 2 years)
- Mortality(Up to 2 years)
- Length of hospital stay(up to 60 days)
- Length of ICU stay(up to 30 days)