Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations (RCT BiPAP)

Vanderbilt University Medical Center

Status: Withdrawn

Conditions: Asthma

Treatments: Device: NIPPV (PALMtop PTV); Device: Volumetric CO2 (NM3); Device: USCOM

Study type: Interventional

Funder types: Other

Identifiers

NCT01497691

111491

Details and patient eligibility

About

Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in children with respiratory insufficiency, emergency department and ICU stays may be shortened, and the need for more invasive and dangerous airway procedures may be decreased. This would result in a change in the standard of care for asthma treatment in emergency departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction with current standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress, and overall improved secondary outcomes.

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 2-18 years old
• For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the Vanderbilt problem list
• For children ages 2-3 years, four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens
• Acute asthma exacerbation
• Pediatric Asthma Score (PAS) ≥ 8
• Parents willing and able to sign consent
• Children over the age of 6 willing to provide assent

Exclusion criteria

• History of congenital heart disease, chronic respiratory disease including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension or any chronic lung disease other than asthma
• History of sickle cell disease
• Recently diagnosed pneumonia
• Current tracheostomy, on home ventilator or home oxygen requirement
• Recent diabetic ketoacidosis
• Requiring immediate intubation
• Weight less than 5 kilograms
• Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway
• A history of prematurity of ≤ 30 weeks gestation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Control

Other group

Description:

This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol.

Treatment:

Device: USCOM

Sham NIPPV

Sham Comparator group

Description:

This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. The pressure settings will be fixed at a positive end-expiratory pressure (PEEP) of 5-8 cm H2O.

Treatment:

Device: NIPPV (PALMtop PTV)

Device: Volumetric CO2 (NM3)

Device: USCOM

BiPAP

Active Comparator group

Description:

This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. Settings will be adjusted based on the age and clinical presentation of the child.

Treatment:

Device: NIPPV (PALMtop PTV)

Device: Volumetric CO2 (NM3)

Device: USCOM