WithdrawnNot Applicable

NiPPV in the Treatment of Acute Asthma Exacerbations

Stopped: PI could not get support for project. PI left UAMS

United States0Started 2017-06-01

Plain-language summary

Study Summary: Title: A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations Principal Investigator: Thomas J. Abramo, MD Hypothesis: For acute moderate to severe pediatric asthma exacerbations the use of NIPPV/BiPAP, in conjunction with current standard of care therapies, will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress and result in improved ventilatory parameters, secondary outcomes and pediatric asthma scores. Study Design: Prospective, randomized controlled trial Study Duration: This study will be conducted over a 36 month period. Sample Size: 240 subjects Population: Children ages 2-17 years of age presenting to the ED with Acute asthma exacerbation and a Pediatric Asthma Score (PAS) ≥ 8. Synopsis: Eligible subjects will be randomized to either a control group or study groups. The study groups will be either a NIPPV/BiPAP group. The subjects in the study groups will continue to receive all standard of care therapies per the asthma severity protocols. All nebulized therapies will be given through the NIPPV circuit. Patients will be assessed by the pediatric asthma score (PAS), measured respiratory parameters, volumetric end tidal carbon dioxide monitoring and measured cardiac parameters. Objectives: A. Evaluate if the use of NIPPV/BiPAP in conjunction with traditional inhaled beta-agonists improves the outcome in pediatric patients with acute moderate to severe asthma in the acute setting. B. Describe the physiology of NIPPV/BiPAP by measuring cardiac parameters in children randomized to a NIPPV group. C. Monitor safety of NIPPV/BiPAP use for acute asthma exacerbations in children. Safety A.: The study must be IRB approved. B.: Appropriate consent and assent documents will be obtained prior to enrolling the subject in the study. C.: A clear safety plan including DSMB will be established to monitor for adverse events. D.: Confidentiality will be ensured for all subjects enrolled in the study.

Who can participate

Age range2 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 2-17 years old * For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the ACH 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

What they're measuring

Decrease in the Pediatric Asthma Score within the designated time frame.

Timeframe: Every hour for a total of 8 hours

Trial details

NCT IDNCT03219736

SponsorArkansas Children's Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-01