WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in th… (NCT07558265) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
United States500 participantsStarted 2026-07
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Prisoner
* Known or apparent pregnant
* Previous enrollment in WINDSURFER
* A patient-specific contraindication makes one assigned study intervention unsafe
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing non-invasive support strategies for acute hypoxic respiratory failure and ARDS in the emergency department — given my specific situation, does my doctor think a non-invasive approach is appropriate for me, or would intubation or another standard treatment be a safer first step?
2The trial is listed as 'not yet recruiting,' so when might it actually open for enrollment, and is waiting for it to begin realistic given how quickly my condition may need to be treated?
3The primary outcome being measured is something called a 'Major Adverse Pulmonary Event' — can my doctor explain what events are included in that category and what that might mean for understanding the risks involved in this study?
4Since this trial is listed as Phase NA, which often applies to studies comparing existing treatments rather than testing a new drug, can my doctor clarify what is actually being compared and whether any of those approaches differ from what I might receive as standard emergency care today?
5If I were to eventually become eligible and enroll, how demanding would participation be — for example, would decisions about my breathing support be made differently than they would be outside the trial, and how would my care team respond if my condition worsened during the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
Timeframe: a) Hospital Death up to 28 days after randomization b) Maximum of 28 ventilator days c) Maximum of 24 NIRS hours