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 range18 Years

SexALL

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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

What they're measuring

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

Trial details

NCT IDNCT07558265

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-08

Contact for this trial

Henry E Wang, MD, MS

614-648-1372 Henry.wang@osumc.edu