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?
This trial explores the best way to provide non-invasive respiratory support for adults in the emergency department with acute hypoxemic respiratory failure, a serious condition where blood oxygen levels drop dangerously low. The trial compares two methods: Non-Invasive Positive Pressure Ventilation (NIPPV), which delivers oxygen under pressure through a face mask, and High-Flow Nasal Oxygen (HFNO), which provides oxygen through a special nasal tube. Researchers will examine how these methods affect survival, the need for more intense breathing assistance, and the duration of support required. Individuals experiencing breathing difficulties and requiring urgent oxygen support might qualify for this study. As an unphased trial, this study offers patients the opportunity to contribute to vital research that could enhance emergency respiratory care.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these non-invasive respiratory support strategies are safe for treating acute hypoxemic respiratory failure?
Previous studies have shown that High-Flow Nasal Oxygen (HFNO) is safe for people with breathing problems. Research indicates that HFNO can ease breathing distress and reduce the need for more invasive treatments. Most people tolerate it well, and serious side effects are rare.
Similarly, Non-Invasive Positive Pressure Ventilation (NIPPV) is considered safe for treating breathing issues. Studies have found that NIPPV can help avoid the need for a breathing tube. Most people handle it without major problems, although it might not work for everyone.
Both treatments have been used in hospitals and offer safe options for people with breathing difficulties.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for Acute Respiratory Distress Syndrome (ARDS) because they offer non-invasive alternatives to traditional mechanical ventilation. High-Flow Nasal Oxygen (HFNO) delivers humidified oxygen through a nasal cannula, providing comfort and ease of use compared to intubation. On the other hand, Non-Invasive Positive Pressure Ventilation (NIPPV) uses a face mask to assist breathing, which might reduce the risk of complications associated with invasive procedures. Both methods aim to improve oxygenation without the need for sedation or an endotracheal tube, potentially leading to quicker recovery times and less hospital resource use.
What evidence suggests that this trial's treatments could be effective for acute hypoxemic respiratory failure?
This trial will compare High-Flow Nasal Oxygen (HFNO) with Non-Invasive Positive Pressure Ventilation (NIPPV) for patients experiencing acute hypoxemic respiratory failure. Studies have shown that HFNO effectively reduces the need for intubation, where a tube is inserted to assist breathing, in patients with low oxygen levels. It often leads to quicker improvement in breathing and comfort. Research indicates that HFNO helps prevent further breathing problems and is generally well tolerated by patients. Meanwhile, NIPPV has been found to lower death rates and shorten hospital stays when used early in patients with sudden lung injury or breathing failure. Evidence suggests that NIPPV helps avoid the need for more invasive breathing support. Both treatments show promising results in improving patient survival and reducing the severity of breathing issues.16789
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?
This trial is for adults (18+) who come to the emergency department with dangerously low blood oxygen and need urgent non-invasive breathing support. People can't join if they have certain facial features, are pregnant, already use home ventilators (except for sleep apnea), or have conditions like advanced COPD or heart failure.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
Trial Overview
The study compares two ways of giving oxygen without surgery: a face mask that pushes air into the lungs (NIPPV) versus high-flow oxygen through nasal tubes (HFNO). Participants are randomly assigned to one method to see which works better and is safer during their hospital stay.
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
Citations
The Impact of High-Flow Nasal Cannula Therapy on Acute ...
The findings show that HFNC is effective in reducing the respiratory distress symptoms, the incidence of invasive ventilation, and the adverse events ...
A randomized controlled trials based meta-analysis
HFNO therapy demonstrated advantages over COT, showing comparable mortality rates and significantly reduced intubation requirements in patients with hypoxemic ...
Ward-Based High-Flow Nasal Oxygen Therapy in Acute ...
A total of 71 (48.9%) patients started HFNO on ICU and continued on the RW, treatment was tolerated in 94% of patients. In-hospital mortality was 24.8% (n = 35) ...
Efficacy of high-flow nasal oxygen therapy started in the ...
Our objective is to compare conventional oxygen therapy to HFNO when they are initiated during the first hour following the patient's arrival at the emergency ...
5.
healthcare-bulletin.co.uk
healthcare-bulletin.co.uk/article/impact-of-high-flow-nasal-oxygen-in-patients-with-acute-hypoxic-respiratory-failure-in-emergency-department-4238/Impact of High Flow Nasal Oxygen in Patients with Acute ...
Results: HFNC resulted in significantly faster improvement in respiratory and oxygenation parameters and significantly higher patient comfort ...
High-Flow Nasal Oxygen for Severe Hypoxemia - PMC
After institution of IMV, 7.1% of HFNO patients and 4.3% of NIV patients with PaO2/FIO2 ratio ⩽300 mm Hg and bilateral chest infiltrates lost ARDS criteria.
7.
journals.lww.com
journals.lww.com/ccmjournal/fulltext/2024/01000/safety_and_outcome_of_high_flow_nasal_oxygen.4.aspxSafety and Outcome of High-Flow Nasal Oxygen Therapy...
In this large cohort of hypoxemic patients with COVID-19, initiation of HFNO outside the ICU was safe, and clinical outcomes were similar to initiation in the ...
High-flow nasal cannula for Acute Respiratory Distress ...
In the study period, 196 patients with bilateral pneumonia were admitted to our pulmonology unit, 40 of whom were treated with HFNC due to the presence of ARDS.
Safe Use of High-Flow Nasal Oxygen (HFNO) With Special ...
This brief current review will discuss the underlying mechanisms of HFNO, its potential use in clinical anesthesia practice, and the risks and benefits of such ...
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