Non-Invasive Ventilation for Acute Respiratory Distress Syndrome
(WINDSURFER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Henry E Wang, MD, MS
Principal Investigator
Ohio State University
Jarrod Mosier, MD
Principal Investigator
University of Arizona
Mark Tidswell, MD
Principal Investigator
Baystate Health
William Meurer, MD
Principal Investigator
University of Michigan - Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Clinical Coordinating Center
Robert Silbergleit, MD
Principal Investigator
University of Michigan - SIREN Clinical Coordinating Center
Valerie Durkalski-Mauldin, PhD
Principal Investigator
Medical University of South Carolina - SIREN Data Coordinating Center
Lai Wei, PhD
Principal Investigator
Ohio State University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Non-Invasive Positive Pressure Ventilation (NIPPV) or High-Flow Nasal Oxygen (HFNO) as initial non-invasive respiratory support
Follow-up
Participants are monitored for safety and effectiveness during hospitalization and a defined post-randomization observation period
Post-hospitalization Follow-up
Participants are monitored for major adverse pulmonary events and other secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- High-Flow Nasal Oxygen
- Non-Invasive Positive Pressure Ventilation
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on Non-Invasive Positive Pressure Ventilation (NIPPV), by face mask.
Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on humidified High-Flow Nasal Oxygen (HFNO), delivered to the participant through a specially designed nasal cannula.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Michigan
Collaborator
Medical University of South Carolina
Collaborator
University of Arizona
Collaborator
Baystate Medical Center
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.