Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus

Southern Illinois University

Status and phase: Withdrawn; Phase 1

Conditions: Status Asthmaticus

Treatments: Other: NPPV plus standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT01188473

BAS-SIU-10-005

Details and patient eligibility

About

Status asthmaticus is recognized as a common cause of morbidity in children in the United States. In recent years, hospitalization rates have reached an all time high. This study will evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive Pressure Ventilation (NPPV)to regular care in children with moderate to moderately severe status asthmaticus.

Full description

Status asthmaticus is defined as severe asthma that fails to respond to inhaled short acting β agonists (SABA), oral or intravenous steroids, and oxygen, leading to hospital admission for further management (1). In 2004, asthma exacerbations led to 3% (198,000) of all hospitalizations and 2.5 deaths per 1 million populations in the 0-17 year age group (2).

This prospective, unblinded, randomized controlled, pilot clinical trial will compare NPPV plus standard of care versus standard of care alone in children admitted for status asthmaticus. NPPV refers to the delivery of pressurized gas through an external interface such as a nasal or oronasal mask, connected to a pressure targeted ventilator. In other words, it provides ventilator support without the use of an endotracheal tube.

This study will investigate the safety, tolerability and efficacy of early initiation of non-invasive NPPV in pediatric patients admitted with status asthmaticus.

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children, 1- 18 years of age, with a known history of asthma admitted to the PICU at St John's Children's Hospital with status asthmaticus
• clinical asthma score (CAS) between 3 - 8 after receiving one dose of systemic steroid, 1 hour of continuous albuterol (SABA), and 3 doses of ipratropium bromide
• written informed consent from the patient's parent or legal guardian

Exclusion criteria

• no previous history of asthma,
• absence of airway protective reflexes,
• absence of respiratory drive,
• excessive oral secretions,
• need for emergent intubation as determined by the attending physician,
• facial or airway anomaly or injury precluding the use of tight fitting mask

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

NPPV plus standard of care

Experimental group

Description:

NPPV initiated early and for a prolonged period of time in addition to standard of care in the management of children admitted to the hospital with status asthmaticus

Treatment:

Other: NPPV plus standard of care

Control: standard of care alone

No Intervention group

Description:

standard of care in the management of children admitted to the hospital with status asthmaticus