An interventional study of Standard of Care - Nasal Cannula and High-flow nasal cannula in Acute Respiratory Failure, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
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).
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 6 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: High-flow nasal cannula · Other: HFNC plus non-invasive ventilation
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 · Other: High-flow nasal cannula · Other: HFNC plus non-invasive ventilation
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.
Also known as: HFNC
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).
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.
Time frame: 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.
Time frame: first 48 hours
Mortality
Assess mortality of enrolled patients by quarterly retrospective chart reviews.
Time frame: Up to 2 years
Length of hospital stay
Compare length of hospitalization between groups
Time frame: up to 60 days
Length of ICU stay
Compare length of ICU stay between groups
Time frame: up to 30 days
Discharge location
was patient discharged to home, rehabilitation facility, skilled nursing, death; compare between groups
Time frame: up to 60 days
Complications
Compare complications (such as need to be mechanically ventilated, infections, etc.) between groups
Time frame: up to 2 years
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Oklahoma