Bilevel Positive Airway Pressure for Asthma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat children with severe asthma attacks by using bilevel positive airway pressure (BPAP) early in the emergency room. The study compares the effects of BPAP alongside usual asthma treatments versus standard treatments alone to determine if BPAP can safely improve symptoms and reduce the need for intensive care. Children who frequently experience severe asthma attacks and visit the ER may be suitable for this study. The trial aims to gather data to assess whether this approach merits larger-scale testing in the future. As an unphased trial, it offers participants a unique opportunity to contribute to pioneering research that could shape future asthma treatments.
Do I have to stop taking my current medications for the 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 bilevel positive airway pressure (BPAP) is safe for children with severe asthma exacerbations?
Research has shown that bilevel positive airway pressure (BPAP) is safe and effective for children with severe asthma. Studies have found that BPAP improves breathing and oxygen levels without causing additional irritation. Several studies confirm its safety for treating children during severe asthma attacks. Therefore, BPAP could be a beneficial option to help children breathe easier during asthma struggles.12345
Why are researchers excited about this trial?
Researchers are excited about using Bilevel Positive Airway Pressure (BPAP) for asthma because it offers a new approach to managing respiratory distress by providing non-invasive ventilation. Unlike standard asthma treatments, which typically involve inhalers and medications to open the airways, BPAP can help patients breathe more easily by delivering pressurized air through a mask. This method can be particularly beneficial in acute asthma attacks when immediate relief is needed. Additionally, combining BPAP with continuous albuterol could enhance drug delivery and improve overall respiratory function, providing a potentially more effective treatment for those with severe asthma symptoms.
What evidence suggests that BPAP is effective for severe asthma exacerbations?
This trial will compare bilevel positive airway pressure (BPAP) plus continuous albuterol with continuous albuterol alone for asthma. Studies have shown that BPAP can assist children during severe asthma attacks. Research indicates that BPAP eases breathing by reducing the effort required by the lungs, helping children breathe better during asthma flare-ups. One study showed that BPAP improved breathing rates and oxygen levels without causing additional irritation. Another study found that BPAP is safe and can reduce the need for more intensive care in children with severe asthma. These findings suggest BPAP might be a valuable addition to standard asthma treatments in emergency situations.23567
Are You a Good Fit for This Trial?
This trial is for children who come to the emergency department with a severe asthma attack. Participants must be able to use BPAP and not have other major health issues that would prevent safe participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive either BPAP plus continuous albuterol or continuous albuterol alone during an approximately 2-hour intervention period
Monitoring
Participants are monitored for safety and effectiveness, including adverse events and clinical outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bilevel Positive Airway Pressure (BPAP)
Trial Overview
The study compares early use of bilevel positive airway pressure (BPAP) along with standard asthma treatment versus standard treatment alone in kids with severe asthma attacks, to see if BPAP is safe, practical, and possibly helpful.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm will receive BPAP plus continuous albuterol administered via FDA-approved delivery systems according to routine clinical practice. BPAP will be delivered using an appropriately sized nasal or face mask and managed by trained respiratory therapists and/or nursing staff per standard care. Continuous albuterol will be administered through the BPAP circuit per manufacturer recommendations or site-specific practice. BPAP settings may be adjusted at the discretion of the treating clinician. Participants will remain on BPAP for approximately 2 hours or until continuous albuterol is discontinued, whichever occurs first. After the intervention period, continuation of BPAP will be at the treating clinical team's discretion.
Participants randomized to this arm will receive continuous albuterol administered via FDA-approved delivery systems according to routine clinical practice. Non-invasive ventilation (including BPAP or CPAP) will not be initiated during the first approximately 2 hours after randomization unless clinically indicated; if initiated, the reason will be documented. All other aspects of care, including oxygen and adjunctive therapies, will be provided at the discretion of the treating clinical team per standard practice. After the intervention period, escalation of care, including initiation of BPAP or other respiratory support, will be determined by the treating clinician.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Children's Hospital of Philadelphia
Collaborator
Nationwide Children's Hospital
Collaborator
University of Utah
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
Clinical outcomes after bilevel positive airway pressure ...
Clinical outcomes after bilevel positive airway pressure treatment for acute asthma exacerbations.
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Data Collection and Outcomes: Data collected will include demographics, asthma history, severity scores (e.g., PRAM), vital signs ...
Bilevel Positive Airway Pressure ventilation efficiently ...
BiPAP seemed efficient in improving respiratory rate and oxygenation in our study. It does not seem to cause additional irritation.
4.
researchgate.net
researchgate.net/publication/270221038_Clinical_Outcomes_After_Bilevel_Positive_Airway_Pressure_Treatment_for_Acute_Asthma_ExacerbationsClinical Outcomes After Bilevel Positive Airway Pressure ...
Bilevel positive airway pressure (BiPAP) in acute paediatric asthmatics can be an effective treatment. BiPAP works by unloading fatigued ...
Bilevel positive airway pressure (BPAP) for moderate-to ...
... BPAP is effective and safe in children with acute moderate-to-severe asthma exacerbations. Before conducting a definitive trial, we need to first carry out ...
Bilevel Positive Airway Pressure in the Treatment of Status ...
Conclusions: These results suggest that the addition of BiPAP in treating pediatric status asthmaticus is safe and well tolerated. This intervention shows ...
7.
pulmonologyadvisor.com
pulmonologyadvisor.com/news/bilevel-positive-airway-pressure-ventilation-safe-for-children-with-severe-asthma/Bilevel Positive Airway Pressure Ventilation Safe for ...
Investigators found data that showed Bilevel Positive Airway Pressure ventilation was safe for treatment in children with severe asthma.
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