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

RecruitingNAAges 18 Years - anyAllOhio State University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years * Presenting to the Emergency Department (ED) with Acute Hypoxemic Respiratory failure (AHRF), defined as: * \[(respiratory rate โ‰ฅ25 breaths/min) AND (requiring โ‰ฅ6 L/min of oxygen required to maintain SpO2 โ‰ฅ90%), OR SpO2:FiO2 ratio\<250\] OR * Arrival at ED on prehospital Non-Invasive Respiratory Support (NIRS). * Clinical need for NIRS * Randomization โ‰ค2 hours after identification of need for NIRS * Randomization โ‰ค6 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
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What it tests

  • Non-Invasive Positive Pressure Ventilation
  • High Flow Nasal Oxygen
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Where

6 sites
Banner University Medical Center Tucson
Tucson, United States
University of Michigan Medical Center
Ann Arbor, United States
Ohio State East Hospital
Columbus, United States
OSU Wexner Medical Center
Columbus, United States
Intermountain Medical Center
Murray, United States
Harborview Medical Center
Seattle, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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