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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to give oxygen without a breathing tube: a face mask that uses pressure and small tubes in the nose that give a high flow of oxygen. It is for adults in the emergency department whose blood oxygen is dangerously low. Researchers will compare safety, survival, and how long people need help breathing.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You are in the emergency department with dangerously low blood oxygen. You must either breathe at least 25 times a minute and need at least 6 liters of oxygen a minute to keep your oxygen level at 90% or higher, or have an oxygen-level-to-oxygen-dose ratio below 250.
  • Instead of meeting those oxygen and breathing measurements, you may qualify if you arrive already getting breathing support without a breathing tube.
  • You need breathing support without a breathing tube.
  • You can be assigned to treatment within 2 hours after this need is found and within 6 hours after arriving at the emergency department.

Who can't join

  • You urgently need a breathing tube, or your heart or breathing has stopped.
  • You are not in the emergency department, or you were transferred from another emergency department.
  • Your face or head shape prevents use of either oxygen device, or you have a surgical breathing opening in your neck.
  • You need more than 0.2 micrograms/kg/minute of norepinephrine, or a similar drug dose, to keep your average blood pressure above 65 mmHg.
  • You already have an order not to restart your heart or not to use a breathing tube, or you have identification saying you do not want to take part.
  • You use pressure-based breathing support at home for a condition other than sleep apnea, have advanced COPD (long-term lung disease), or have advanced heart failure.
  • You are a prisoner, are known or appear to be pregnant, or have joined WINDSURFER before.
  • A health issue makes either study treatment unsafe for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (6)

AZ

MI

OH

UT

WA