Recruiting

NIPPV vs. HFNOWIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department

Sponsor:

Ohio State University

Code:

NCT07558265

Conditions

Acute Hypoxic Respiratory Failure

Acute Respiratory Distress Syndrome (ARDS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Invasive Positive Pressure Ventilation

High Flow Nasal Oxygen

Study Details

Brief 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)

Study ID

NCT07558265

Start date

Aug 18, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Non-Invasive Positive Pressure Ventilation (NIPPV)

Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on Non-Invasive Positive Pressure Ventilation (NIPPV), by face mask.

active comparator: High Flow Nasal Oxygen (HFNO)

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.

Interventions

Non-Invasive Positive Pressure Ventilation

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

High Flow Nasal Oxygen

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

Primary outcome measure

Number of Subjects with Major Adverse Pulmonary Event (MAPE) [ Time Frame: a) Hospital Death up to 28 days after randomization b) Maximum of 28 ventilator days c) Maximum of 24 NIRS hours ]

Central Contacts and Locations

Central contacts

Henry E Wang, MD, MS

614-648-1372 Henry.wang@osumc.edu

Valerie L Durkalski-Mauldin, PhD

843-876-1911 durkalsv@musc.edu

Locations

Banner University Medical Center Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Jarrod Mosier, MD

520-626-2038 jmosier@arizona.edu

Beth Campbell

520-626-8388 bsalvag@arizona.edu

Principal Investigator:

Jarrod Mosier, MD

University of Michigan Medical Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

William Meurer, MD

734-936-5947 meurer@umich.edu

Sai L Mamillapalli

mamillap@med.umich.edu

Principal Investigator:

William Meurer, MD

Ohio State East Hospital

Recruiting

Columbus, Ohio, United States, 43203

Contacts

Jason Bischof, MD

614-293-8305 jason.bischof@osumc.edu

Michael Hill

614-293-6185 michael.hill@osumc.edu

Principal Investigator:

Jason Bischof, MD

OSU Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jason Bischof, MD

614-293-8305 jason.bischof@osumc.edu

Michael Hill

614-293-6185 michael.hill@osumc.edu

Principal Investigator:

Jason Bischof, MD

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Troy Madsen, MD

troy.madsen@imail.org

Sarah Duckworth

801-507-4979 sarah.duckworth@imail.org

Principal Investigator:

Troy Madsen, MD

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Nick Johnson, MD

415-793-1716 nickj45@uw.edu

Joshua Acidera

josha15@uw.edu

Principal Investigator:

Nick Johnson, MD

More Information

Sponsor

Ohio State University

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

Acute Hypoxemic Respiratory Failure
Acute Decompensated Heart Failure
Acute Respiratory Distress Syndrome
BiPAP
BPAP
COPD
Chronic Obstructive Pulmonary Disease
Continuous Positive Airway Pressure
HFNO
High-Flow Nasal Oxygen
EPAP
Expiratory Positive Airway Pressure
FiO2
Inspired Oxygen Fraction
IMV
Invasive Mechanical Ventilation
IPAP
Inspiratory Positive Airway Pressure
MAPE
Major Adverse Pulmonary Events
MV
Mechanical Ventilation
NIRS
Non-Invasive Respiratory Support
NIPPV
Non-Invasive Positive Pressure Ventilation
PaCO2
Partial pressure of carbon dioxide in arterial blood
PaO2
Partial pressure of oxygen in arterial blood
P:F
Ratio of PaO2 to FiO2
RR
Respiratory Rate
P-SILI
Patient Self-Inflicted Lung Injury
RRT
Renal Replacement Therapy
RSFD
Respiratory Support Free Days
S:F
Ratio of SpO2 to FiO2
SpO2
Transcutaneous measurement of peripheral arterial saturation
UADE
Unanticipated Adverse Device Effects
VAS
Visual Analog Scale
VDays
Ventilator Days
VFD
Ventilator-Free Days
WINDSURFER
WIN ratio analysis to determine a strategy of non-invasive support for respiratory failure in the emergency department trial
WR
WIN Ratio
Bilevel Positive Airway Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.