WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
[(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
Disqualifiers
Urgent need for intubation
Cardiac arrest
Respiratory arrest
Patient not located in the ED
Trial design
Design model
Parallel
Treatments tested in this trial
Non-Invasive Positive Pressure Ventilation
DeviceOxygen is delivered with positive pressure through a face mask covering the nose and mouth.
High Flow Nasal Oxygen
DeviceHumidified oxygen is delivered to the participant through a specially-designed nasal cannula.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Non-Invasive Positive Pressure Ventilation (NIPPV)Active comparator 1 intervention
Group B: High Flow Nasal Oxygen (HFNO)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
Composite of: 1. Hospital Death 2. Ventilator Days 3. Non-Invasive Respiratory Support (NIRS) Hours
Time frame
a) Hospital Death up to 28 days after randomization b) Maximum of 28 ventilator days c) Maximum of 24 NIRS hoursSecondary outcomes
1
Number of Subjects with New or worsening pneumonia/pneumonitis
Development or worsening of air-space disease, as identified by radiologist interpretation of chest x-rays and comparison with first chest x-ray.
Time frame
Up to hospital discharge or 7 days of randomization, whichever comes first.2
Number of Subjects with Acute Respiratory Distress Syndrome (ARDS)
Development or worsening of ARDS. Berlin and European Society of Intensive Care Medicine ARDS criteria, both intubated and non-intubated patients: * Bilateral opacities on chest x-ray or computed tomography. * Decreased PaO2:FiO2 or SpO2:FiO2 ratio * Respiratory failure not explained by heart failure or volume overload.
Time frame
Up to hospital discharge or 7 days of randomization, whichever comes first.3
Number of Subjects with New or worsening shock
Requirement for vasopressors (\>0.2 mcg/kg/min norepinephrine or equivalent) for \>1 hour to maintain systolic blood pressure ≥90 mm Hg.
Time frame
Up to hospital discharge or 72 hours of randomization, whichever comes first.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov