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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07558265
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-Invasive Positive Pressure Ventilation — DEVICE
    Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
  • High Flow Nasal Oxygen — DEVICE
    Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.

Study Details

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

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Ohio State East HospitalColumbusOhio43203
Jason Bischof, MD
[email protected]
614-293-8305
Michael Hill
[email protected]
614-293-6185
Jason Bischof, MD (PRINCIPAL_INVESTIGATOR)
OSU Wexner Medical CenterColumbusOhio43210
Jason Bischof, MD
[email protected]
614-293-8305
Michael Hill
[email protected]
614-293-6185
Jason Bischof, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State East Hospital· Columbus, OHOSU Wexner Medical Center· Columbus, OH

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