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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61HL158814-01A1 | U.S. NIH Grant/Contract | View source |
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Interim Analysis showed futility for the primary outcome measure.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiPAP | Experimental | Patients randomized to the study group (BiPAP) will receive continuous nebulized albuterol through the FDA approved Respironics Trilogy BiPAP machine as per routine practice and institutional guidelines for albuterol dosing. Participants will receive BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. |
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| Control | Sham Comparator | Patients randomized to the control group (sham BiPAP) will receive continuous nebulized albuterol through the same set-up as the study group and institutional guidelines for albuterol dosing. Participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy per the treating clinician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi-level Positive Airway Pressure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Continuous Beta-Agonist Therapy | Number of hours until discontinuation of continuous beta-agonist therapy | Through study completion, an average of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At two and four hours after starting the intervention |
| Change in Respiratory Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick T Wilson, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Colorado | Denver | Colorado | 80238 | United States |
Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).
Beginning 6 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Sham Bi-level Positive Airway Pressure | Device | 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. |
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Change in respiratory rate in breaths per minute from baseline to two and four hours |
| At two and four hours after starting the intervention |
| Invasive Mechanical Ventilation | Rate of participants requiring endotracheal intubation for invasive mechanical ventilation | Four-hour study intervention |
| Admission to Pediatric Intensive Care Unit (PICU) | Rate of admissions to the Pediatric Intensive Care Unit (PICU) | 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 | Through entire hospitalization, an average of 72 hours |
| Hospital Readmissions | Rate of hospital readmission within 7 days | 7 days from hospital discharge date |
| Duration of Bilevel Positive Airway Pressure (BiPAP) | Duration in hours of BiPAP administration | Through entire hospitalization, an average of 72 hours |
| Adverse Events | Pneumothorax, pneumomediastinum, sub-cutaneous emphysema, hypotension, vomiting, aspiration, skin breakdown | 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 | 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 | At 2 hour and 4 hours after starting the intervention |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |