Clinical trial NCT01188473: Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus
Official title: Safety and Efficacy of Early Initiation of Noninvasive Positive Pressure Ventilation in Pediatric Patients Admitted With Status Asthmaticus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Status Asthmaticus
Keywords: Status Asthmaticus
Noninvasive Positive Pressure Ventilation
Asthma in Children
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical asthma score (CAS)
timeFrame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Secondary outcomes:
measure: heart rate
timeFrame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
measure: being able to wear the mask
timeFrame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
measure: transcutaneous oxygen saturation
timeFrame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
measure: mental status
timeFrame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
measure: supplemental oxygen
timeFrame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
measure: NPPV related side effects
timeFrame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Sangita Basnet, MD
role: PRINCIPAL_INVESTIGATOR
References: