NCT07558265 · Ohio State University
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
(WINDSURFER)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Non-Invasive Positive Pressure Ventilation
Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
DEVICE
High Flow Nasal Oxygen
Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.
Primary outcome measures
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
Time frame: a) Hospital Death up to 28 days after randomization b) Maximum of 28 ventilator days c) Maximum of 24 NIRS hours
Composite of: 1. Hospital Death 2. Ventilator Days 3. Non-Invasive Respiratory Support (NIRS) Hours
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 ED
- Craniofacial anatomic features that prohibit either Non-Invasive Positive Pressure Ventilation (NIPPV) or High Flow Nasal Oxygen (HFNO) interface
- Tracheostomy or laryngectomy stoma
- Hemodynamic instability requiring \>0.2mcg/kg/min of norepinepherine (or equivalent) to maintain mean arterial pressure \>65mmHg
- Pre-existing "do not resuscitate" or "do not intubate" order
- Home use of non-invasive positive-pressure ventilation for respiratory support of a medical condition other than sleep apnea
- Transferred from another Emergency Department
- History of advanced chronic obstructive pulmonary disease
- History of advanced heart failure
- Presence of opt-out identification
- Known or apparent pregnant
- Previous enrollment in WINDSURFER
- A patient-specific contraindication makes one assigned study intervention unsafe
Where
- Tucson, Arizona
- Ann Arbor, Michigan
- Columbus, Ohio
- Murray, Utah
- Seattle, Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Michigan, Medical University of South Carolina, University of Arizona, Baystate Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations