Acute Hypoxic Respiratory FailureWINDSURFERNCT07558265
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
A study testing Non-Invasive Positive Pressure Ventilation and High Flow Nasal Oxygen in people with Acute Hypoxic Respiratory Failure and Acute Respiratory Distress Syndrome (ARDS), run by Ohio State University at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Non-Invasive Positive Pressure Ventilation and High Flow Nasal Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Aug 2026to Aug 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Prisoner
- Known or apparent pregnant
- Previous enrollment in WINDSURFER
- A patient-specific contraindication makes one assigned study intervention unsafe
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
William Meurer, MD, 734-936-5947, meurer@umich.edu
Sai L Mamillapalli, mamillap@med.umich.edu
- Recruiting
Ohio State East Hospital
Columbus, Ohio, 43203
Jason Bischof, MD, 614-293-8305, jason.bischof@osumc.edu
Michael Hill, 614-293-6185, michael.hill@osumc.edu
- Recruiting
OSU Wexner Medical Center
Columbus, Ohio, 43210
Jason Bischof, MD, 614-293-8305, jason.bischof@osumc.edu
Michael Hill, 614-293-6185, michael.hill@osumc.edu
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Troy Madsen, MD, troy.madsen@imail.org
Sarah Duckworth, 801-507-4979, sarah.duckworth@imail.org
- Recruiting
Harborview Medical Center
Seattle, Washington, 98104
Nick Johnson, MD, 415-793-1716, nickj45@uw.edu
Joshua Acidera, josha15@uw.edu
- Recruiting
Banner University Medical Center Tucson
Tucson, Arizona, 85719
Jarrod Mosier, MD, 520-626-2038, jmosier@arizona.edu
Beth Campbell, 520-626-8388, bsalvag@arizona.edu
About this study
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.
Read more
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
Read the detailed 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). Both modalities are accepted standards of care; however, their relative effectiveness and safety when applied early in the ED remain uncertain. Prior comparative studies have largely been conducted in intensive care settings, enrolled selected patient populations, or focused on single outcomes such as intubation or mortality. Consequently, equipoise persists regarding the optimal initial NIRS strategy for ED patients with undifferentiated AHRF.
The WINDSURFER trial (WIN ratio analysis to Determine a strategy of non-invasive SUpport for Respiratory Failure in the EmeRgency Department) is designed to compare two strategies of non-invasive respiratory support-NIPPV and HFNO-with respect to clinically meaningful outcomes in adult ED patients with acute hypoxemic respiratory failure.
The trial is conducted at multiple hospitals participating in the NIH funded Strategies to Innovate Emergency Care Clinical Trials Network (SIREN), enabling enrollment across diverse emergency care environments.
The study enrolls adult patients early in their ED course, reflecting the population in which initial respiratory support decisions are most consequential.
Participants are randomly assigned in equal proportions to one of the two study strategies, with allocation managed centrally through a secure electronic system to ensure balance across sites.
The assigned strategy is implemented as the initial approach to non invasive respiratory support for a defined protocolized period, after which ongoing respiratory management is determined by the treating clinical team according to standard clinical practice.
Clinical data are collected from the medical record and study specific assessments to characterize baseline features, treatment course, and in hospital events. Follow up extends through hospitalization and a defined post randomization observation period to ensure complete capture of relevant clinical outcomes.
Ethical Considerations: Because AHRF is a life-threatening emergency requiring immediate intervention and patients frequently lack decision making capacity at presentation, the study is conducted under Exception From Informed Consent (EFIC) in accordance with Food and Drug Administration (FDA) regulations (21 CFR 50.24). Community consultation and public disclosure are completed prior to enrollment at each site. Participants or their Legally Authorized Representatives are informed of enrollment at the earliest feasible opportunity and may withdraw from the study at any time.
- Being tested
- Non-Invasive Positive Pressure Ventilation, High Flow Nasal Oxygen
- Keywords
- Acute Hypoxemic Respiratory Failure, Acute Decompensated Heart Failure, Acute Respiratory Distress Syndrome, BiPAP, BPAP, COPD, Chronic Obstructive Pulmonary Disease, Continuous Positive Airway Pressure, HFNO, High-Flow Nasal Oxygen, EPAP, Expiratory Positive Airway Pressure, FiO2, Inspired Oxygen Fraction, IMV, Invasive Mechanical Ventilation, IPAP, Inspiratory Positive Airway Pressure, MAPE, Major Adverse Pulmonary Events
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Positive Pressure VentilationDevice
Also called NIPPV
Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
High Flow Nasal OxygenDevice
Also called HFNO
Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive Positive Pressure Ventilation (NIPPV) | Active comparator | Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on Non-Invasive Positive Pressure Ventilation (NIPPV), by face mask. Receives: Device: Non-Invasive Positive Pressure Ventilation |
| High Flow Nasal Oxygen (HFNO) | Active comparator | Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on humidified High-Flow Nasal Oxygen (HFNO), delivered to the participant through a specially designed nasal cannula. Receives: Device: High Flow Nasal Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
Composite of:
- Hospital Death
- Ventilator Days
- Non-Invasive Respiratory Support (NIRS) Hours
Measured: a) Hospital Death up to 28 days after randomization b) Maximum of 28 ventilator days c) Maximum of 24 NIRS hours
Secondary outcomes (3)
Number of Subjects with New or worsening pneumonia/pneumonitis
Development or worsening of air-space disease, as identified by radiologist interpretation of chest x-rays and comparison with first chest x-ray.
Measured: Up to hospital discharge or 7 days of randomization, whichever comes first.
Number of Subjects with Acute Respiratory Distress Syndrome (ARDS)
Development or worsening of ARDS. Berlin and European Society of Intensive Care Medicine ARDS criteria, both intubated and non-intubated patients:
- Bilateral opacities on chest x-ray or computed tomography.
- Decreased PaO2:FiO2 or SpO2:FiO2 ratio
- Respiratory failure not explained by heart failure or volume overload.
Measured: Up to hospital discharge or 7 days of randomization, whichever comes first.
Number of Subjects with New or worsening shock
Requirement for vasopressors (>0.2 mcg/kg/min norepinephrine or equivalent) for >1 hour to maintain systolic blood pressure ≥90 mm Hg.
Measured: Up to hospital discharge or 72 hours of randomization, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start18 Aug 2026
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-Invasive Positive Pressure Ventilation (NIPPV) or High Flow Nasal Oxygen (HFNO), maintained for 24 hours from randomization. NIPPV will consist of Bilevel Positive Airway Pressure (BPAP).
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Michigan, Medical University of South Carolina, University of Arizona, Baystate Medical Center
- Responsible party
- Principal investigator, Henry Wang, MD, Ohio State University
- Investigators
- Henry E Wang, MD, MS, Principal investigator, Ohio State UniversityJarrod Mosier, MD, Principal investigator, University of ArizonaMark Tidswell, MD, Principal investigator, Baystate HealthWilliam Meurer, MD, Study director, University of Michigan - Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Clinical Coordinating CenterRobert Silbergleit, MD, Study director, University of Michigan - SIREN Clinical Coordinating CenterValerie Durkalski-Mauldin, PhD, Principal investigator, Medical University of South Carolina - SIREN Data Coordinating CenterLai Wei, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558265
- Sponsor's protocol ID
- UG3HL175260
- Other IDs
- UG3HL175260, U24HL175258
- Acronym
- WINDSURFER
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: After participant enrollment and follow up have been completed and the database has been locked, the Data Coordinating Center (DCC) will prepare a de-identified dataset that will be submitted to the NHLBI data repository managed by the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) or else where as arranged with the Institute. Requests to access the shared data after the trial is completed will be handled by the BioLINCC Coordinating Center.