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

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

Conditions

• Acute Hypoxic Respiratory Failure
• Acute Respiratory Distress Syndrome (ARDS)

Interventions

DEVICE

High Flow Nasal Oxygen

Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.

DEVICE

Non-Invasive Positive Pressure Ventilation

Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Michigan

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• Baystate Medical Center

  collaborator OTHER

• Ohio State University

  lead OTHER

Principal Investigators

• Henry E Wang, MD, MS · Ohio State University

• Jarrod Mosier, MD · University of Arizona

• Mark Tidswell, MD · Baystate Health

• William Meurer, MD · University of Michigan - Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Clinical Coordinating Center

• Robert Silbergleit, MD · University of Michigan - SIREN Clinical Coordinating Center

• Valerie Durkalski-Mauldin, PhD · Medical University of South Carolina - SIREN Data Coordinating Center

• Lai Wei, PhD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2031-08-31

Completion

2031-08-31

FDA Device

Yes

Countries

• United States

Study Locations