Non Invasive Positive Pressure Ventilation in Status Asthmaticus

NCT01403428 | Withdrawn Phase 2 DMC

• 1 other identifier: BAS-SIU-11-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Status Asthmaticus is recognized as a common cause of morbidity in children in the United States (CDC). In recent years, hospitalization rates have reached an all time high. This study will evaluate the effect of early use of noninvasive positive pressure ventilation (NPPV) in children admitted to the pediatric intensive care unit (PICU) with moderate to moderately severe status asthmaticus to test the hypothesis that early initiation of NPPV plus standard of care will result in decreased length of PICU stay, significant improvement in clinical asthma score (CAS) and reduced patient care costs when compared to standard of care alone.

Conditions

Status Asthmaticus

Keywords

Asthma; non invasive ventilation; pediatrics; noninvasive positive pressure ventilation (NPPV)

Outcome Measures

Primary Outcomes (1)

• length of stay

  Number of hours patient hospitalized in PICU

  baseline until transfer from PICU

Secondary Outcomes (4)

• clinical asthma score

  baseline until transfer from PICU

• tolerability

  baseline until transfer from PICU

• patient care costs

  baseline until transfer from PICU

• safety

  baseline until transfer from PICU

Study Arms (2)

NPPV plus standard of care

EXPERIMENTAL

Noninvasive positive pressure ventilation (NPPV) plus standard of care in the management of children admitted to the hospital with status asthmaticus

Other: Noninvasive positive pressure ventilation

Standard of care

NO INTERVENTION

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

Interventions

Noninvasive positive pressure ventilation OTHER

Noninvasive positive pressure ventilation (NPPV) will deliver pressurized gas through a nasal or oronasal mask, connected to a pressure targeted ventilator. NPPV provides ventilator support without the use of an endotracheal tube. Standard of care includes use of corticosteroids, oxygen, short acting β-agonist and inhaled ipratropium bromide.

NPPV plus standard of care

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Known H/O asthma
• With status asthmaticus
• CAS score 2-8 after one dose of systemic steroid, 1 hour of continuous albuterol and 3 doses of ipratropium bromide.

You may not qualify if:

• No previous history of asthma.
• Absence of airway protective reflexes.
• Absence of respiratory drive.
• Problems with clearing 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.
• Discretion of the attending physician depending on the severity of illness

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Links

• Southern Illinois University School of Medicine website
• St. John's Children's Hospital
• American Lung Association - asthma webpage

MeSH Terms

Conditions

Status Asthmaticus; Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Sangita Basnet, MD

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

US (1)