NiPPV in the Treatment of Acute Asthma Exacerbations

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.

Conditions

• Bronchial Asthma
• Status Asthmaticus

Interventions

PROCEDURE

Standard of Care therapies

If at any point during the treatment it is deemed medically necessary by the treating PED attending that a subject from the control arm (Group 1) requires an escalation of therapy, they may be moved from the group to the NIPPV/BiPAP group (Group 2) or be removed from the study (i.e. if intubated).

DEVICE

NiPPV Therapy

If at any point during the treatment it is deemed medically necessary by the treating PED attending that a subject from a NIPPV/BiPAP group (Group 2) is not tolerating NIPPV they may be removed from the study. Patients may not tolerate NIPPV due to agitation, vomiting or need for escalation of care.

PROCEDURE

Routine Respiratory Care

It may be up to the treating physicians discretion to treat patient with other medications that are currently used to treat severe asthma exacerbations, such as Epinephrine and Terbutaline

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute

  lead OTHER

Principal Investigators

• Thomas J Abramo, MD · UAMS/ACH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2019-01-01

Completion

2019-01-01

FDA Device

Yes

Countries

• United States

Study Locations