WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
WINDSURFER
2 other identifiers
interventional
500
1 country
19
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2026
CompletedFirst Posted
Study publicly available on registry
April 30, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2031
Study Completion
Last participant's last visit for all outcomes
August 1, 2031
May 5, 2026
April 1, 2026
5.1 years
April 23, 2026
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
Composite of: 1. Hospital Death 2. Ventilator Days 3. Non-Invasive Respiratory Support (NIRS) Hours
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
Up to hospital discharge or 7 days of randomization, whichever comes first.
Number of Subjects with Acute Respiratory Distress Syndrome (ARDS)
Up to hospital discharge or 7 days of randomization, whichever comes first.
Number of Subjects with New or worsening shock
Up to hospital discharge or 72 hours of randomization, whichever comes first.
Study Arms (2)
Non-Invasive Positive Pressure Ventilation (NIPPV)
ACTIVE COMPARATORParticipants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on Non-Invasive Positive Pressure Ventilation (NIPPV), by face mask.
High Flow Nasal Oxygen (HFNO)
ACTIVE COMPARATORParticipants (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.
Interventions
Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Prisoner
- Known or apparent pregnant
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Baystate Medical Centercollaborator
- Medical University of South Carolinacollaborator
- University of Arizonacollaborator
- University of Michigancollaborator
Study Sites (19)
Banner University Medical Center Tucson
Tucson, Arizona, 85719, United States
UCSD La Jolla
San Diego, California, 92037, United States
UCSD Hillcrest
San Diego, California, 92103, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
The University of Chicago Medical Center
Chicago, Illinois, 60615, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Baystate Medical Center
Springfield, Massachusetts, 01107, United States
Henry Ford Hospital
Detroit, Michigan, 48207, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55423, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State East Hospital
Columbus, Ohio, 43203, United States
OSU Wexner Medical Center
Columbus, Ohio, 43210, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
VCU Medical Center
Richmond, Virginia, 23298, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henry E Wang, MD, MS
Ohio State University
- PRINCIPAL INVESTIGATOR
Jarrod Mosier, MD
University of Arizona
- PRINCIPAL INVESTIGATOR
Mark Tidswell, MD
Baystate Health
- STUDY DIRECTOR
William Meurer, MD
University of Michigan - Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Clinical Coordinating Center
- STUDY DIRECTOR
Robert Silbergleit, MD
University of Michigan - SIREN Clinical Coordinating Center
- PRINCIPAL INVESTIGATOR
Valerie Durkalski-Mauldin, PhD
Medical University of South Carolina - SIREN Data Coordinating Center
- PRINCIPAL INVESTIGATOR
Lai Wei, PhD
Ohio State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 23, 2026
First Posted
April 30, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
August 1, 2031
Study Completion (Estimated)
August 1, 2031
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After data set locked and submitted to BioLINCC.
- Access Criteria
- Request to BioLINCC.
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.