NIRS for EDResp: Which first helps hypoxemic adults best?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter trial, adults presenting to the ED with acute hypoxemic respiratory failure are randomly assigned to receive either non-invasive positive pressure ventilation or high-flow nasal oxygen as the initial respiratory support. The study focuses on clinically important outcomes such as survival, need for invasive mechanical ventilation, and duration of respiratory support during hospitalization. Participants are enrolled within hours of identifying the need for non-invasive respiratory support and are treated with the assigned modality to determine which approach yields better patient outcomes in the ED setting. The WINDSURFER trial aims to clarify the optimal first-line non-invasive strategy for undifferentiated AHRF in real-world emergency department practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Banner University Medical Center Tucson
  Tucson, Arizona, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• University of Michigan Medical Center
  Ann Arbor, Michigan, United States Recruiting
• Wake Forest Baptist Medical Center
  Winston-Salem, North Carolina, United States Recruiting
• Ohio State East Hospital
  Columbus, Ohio, United States Recruiting
• OSU Wexner Medical Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Henry E Wang, MD, MS — Ohio State University
• Study coordinator: Henry E Wang, MD, MS
• Email: Henry.wang@osumc.edu
• Phone: 614-648-1372

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.