Acute Hypoxic Respiratory Failure study: High Flow Nasal Oxygen
Official title WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
ClinicalTrials.gov ID: NCT07558265
What this study is testing
- What it's testing
- This study aims to find out which of two breathing support methods works better and is safer for people with low blood oxygen levels.
- Who it's for
- The study is looking for adults who arrive at the emergency department with dangerously low blood oxygen levels.
- What's involved
- Participants will be randomly assigned to receive either oxygen through a face mask or high-flow oxygen through a nasal tube. Researchers will also collect blood and urine samples and use sensors to monitor breathing.
- Time commitment
- The study tracks outcomes during the hospital stay, including survival and the need for a breathing machine.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Randomization ≤2 hours after identification of need for NIRS
You likely can't join if
- 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
See the full eligibility criteria
- 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
- Randomization ≤2 hours after identification of need for NIRS
- Randomization ≤6 hours of ED arrival
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- New Haven, Connecticut, United States
- Ann Arbor, Michigan, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Murray, Utah, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; New Haven, Connecticut, United States; Ann Arbor, Michigan, United States; Winston-Salem, North Carolina, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.