WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Ohio State University
Summary
The purpose of this clinical trial is to determine the best initial non-invasive respiratory support (NIRS) strategy for adults who present to the emergency department with acute hypoxemic respiratory failure, a condition in which blood oxygen levels are dangerously low and require urgent treatment. This study compares two commonly used non-invasive respiratory support strategies to evaluate their effectiveness and safety, based on important patient outcomes during hospitalization, including survival, the need for invasive mechanical ventilation, and the duration of respiratory support. Participants will be randomly assigned (with an equal chance) to receive one of the following treatments: * Non-Invasive Positive Pressure Ventilation (NIPPV): Oxygen delivered under pressure through a face mask. * High-Flow Nasal Oxygen (HFNO): Oxygen delivered at high-flow through a specially designed nasal cannula placed in the nostrils. Researchers will compare the two treatment strategies using a hierarchical assessment of major pulmonary outcomes, including: * Hospital survival * Days on mechanical ventilation * Duration of non-invasive respiratory support As part of the study, researchers will collect: * Blood and urine samples * Physiologic measurements (such as chest movement measured through sensors placed on the skin) * Information from participants' medical records
Description
Acute hypoxemic respiratory failure (AHRF) is a serious medical emergency that frequently presents in the emergency department (ED) and requires immediate respiratory support to prevent further clinical deterioration. Patients with AHRF are at high risk for progression to invasive mechanical ventilation and death, and early management decisions may substantially influence outcomes. Non-invasive respiratory support (NIRS) is widely used as first-line therapy for AHRF. Two commonly used NIRS strategies are non-invasive positive-pressure ventilation (NIPPV) and high-flow nasal oxygen (HFNO). Bot…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 years * Presenting to the Emergency Department (ED) with Acute Hypoxemic Respiratory failure (AHRF), defined as: * \[(respiratory rate ≥25 breaths/min) AND (requiring ≥6 L/min of oxygen required to maintain SpO2 ≥90%), OR SpO2:FiO2 ratio\<250\] OR * Arrival at ED on prehospital Non-Invasive Respiratory Support (NIRS). * Clinical need for NIRS * Randomization ≤2 hours after identification of need for NIRS * Randomization ≤6 hours of ED arrival Exclusion Criteria: * Urgent need for intubation * Cardiac arrest * Respiratory arrest * Patient not located in the…
Interventions
- DeviceNon-Invasive Positive Pressure Ventilation
Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
- DeviceHigh Flow Nasal Oxygen
Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.
Locations (2)
- Ohio State East HospitalColumbus, Ohio
- OSU Wexner Medical CenterColumbus, Ohio