The goal of this clinical trial is to study if starting bi-level positive airway pressure (BiPAP), a mask that gives pressure to the lungs, works well for children in the emergency department with moderate to severe asthma attacks. The main questions it aims to answer are: 1. Whether initiation of BiPAP at the same time as continuous beta-agonist therapy (e.g., nebulized albuterol) will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy. 2. Whether early BiPAP changes how the lungs function in children with asthma attacks. 3. Whether children receiving early BiPAP experience more issues or side effects than those children who do not. All children will receive the usual treatment for asthma attacks; if they are still experiencing moderate to severe symptoms after the initial treatment, they will be asked to participate in the study. Participants will then wear a mask while they are receiving the continuous beta-agonist therapy. Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs. Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy. Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team. Researchers will compare BiPAP versus Control (Sham BiPAP) groups to see if there is a difference in how long continuous beta-agonist therapy is needed, how the lungs are functioning, and number or type of side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
An appropriately sized vented BiPAP face mask with a good seal will be applied and monitored by trained respiratory therapists. Patients will be started on an inspiratory peak airway pressure (IPAP) of 10 cm of water and expiratory positive airway pressure (EPAP) of 5 cm of water per Children's Hospital Colorado (CHCO) clinical pathway. BiPAP pressures will be titrated to effect per the treating physician, using assessment of physical examination, vitals, and asthma score per institutional clinical pathway. Study participants will remain on BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the ongoing use of BiPAP or not.
The sham BiPAP will have pressure attenuated using an orifice restrictor as described in previous double blinded studies using sham non-invasive ventilation. With this set-up pressures no greater than 2 cm of water have been documented at the location of the face mask. This will ensure that the patient is not receiving positive pressure with any effectiveness or deleterious effects. Study participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the use of BiPAP or not.
Childrens Hospital Colorado
Denver, Colorado, United States
Duration of Continuous Beta-Agonist Therapy
Number of hours until discontinuation of continuous beta-agonist therapy
Time frame: Through study completion, an average of 24 hours
Change in Pediatric Respiratory Assessment Measure (PRAM)
Change in Pediatric Respiratory Assessment Measure (PRAM) from baseline to two and four hours, minimum score of 0 and maximum score of 12, the higher the score the more severe the disease
Time frame: At two and four hours after starting the intervention
Change in Respiratory Rate
Change in respiratory rate in breaths per minute from baseline to two and four hours
Time frame: At two and four hours after starting the intervention
Invasive Mechanical Ventilation
Rate of participants requiring endotracheal intubation for invasive mechanical ventilation
Time frame: Four-hour study intervention
Admission to Pediatric Intensive Care Unit (PICU)
Rate of admissions to the Pediatric Intensive Care Unit (PICU)
Time frame: Through entire hospitalization, an average of 72 hours
Total Length of Stay in Hospital
Total length of stay in hours in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), and hospital floor
Time frame: Through entire hospitalization, an average of 72 hours
Hospital Readmissions
Rate of hospital readmission within 7 days
Time frame: 7 days from hospital discharge date
Duration of Bilevel Positive Airway Pressure (BiPAP)
Duration in hours of BiPAP administration
Time frame: Through entire hospitalization, an average of 72 hours
Adverse Events
Pneumothorax, pneumomediastinum, sub-cutaneous emphysema, hypotension, vomiting, aspiration, skin breakdown
Time frame: Four-hour study intervention
Change in Pulse Oxygen Saturation
Change in pulse oxygen saturation (range from 0 to 100%) from baseline to two and four hours
Time frame: At 2 hour and 4 hours after starting the intervention
Change in Heart Rate
Change in heart rate in beats per minute from baseline to two and four hours
Time frame: At 2 hour and 4 hours after starting the intervention
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