Pediatric, Asthma, Acute Exacerbation, Pediatric ICU Clinical Trial
Official title:
Use of High Frequency Chest Compression (HFCC) in Pediatric Status Asthmaticus
Asthma is a disease resulting in mucus hypersecretion and airways obstruction. This causes difficulty breathing. The High Frequency Chest Compressor (HFCC) is a device that has been shown to decrease respiratory complications in individuals with severe disability who are unable to clear airway secretions. There is a lack of studies using this device in children with asthma. The device has been shown in a study to be safe in children with asthma. The investigators propose that using this device in our pediatric patients hospitalized in the pediatric ICU with asthma will result in decreased pediatric ICU stay. The investigators will also look at asthma severity, total days of hospital stay and chest discomfort while on therapy.
Background: Asthma is the third largest cause of hospitalization in children under 15 years
of age. It is a reversible obstructive lung disease caused by airway inflammation and
constriction of the airway smooth muscle. Mucus producing glands of the airway become
enlarged resulting in overproduction of mucus. All those factors result in airflow
obstruction with airtrapping, ventilation/perfusion mismatch and hypoxia. Therapies such as
beta-agonists (i.e. albuterol), anti-cholinergics (i.e. atrovent) and steroids are used for
an acute asthma attack. Unfortunately, patients may develop status asthmaticus, in which a
severe attack does not respond to nebulized bronchodilators, and require intensive care
admission.
HFCC is an FDA (1988 under Class II 510K) approved device/modality of chest physiotherapy
which has been utilized in patients with mucus hypersecretion, atelectasis and pneumonia.
There is a paucity of pediatric studies. A comparative retrospective/prospective data
analysis on exacerbations and hospitalizations in medically fragile (profoundly disabled)
children using outpatient HFCC showed that use of this therapy reduced days of
hospitalization for pulmonary exacerbations. Long term use in quadriplegic children reduced
pulmonary secretions, incidence of pneumonia, and number of hospitalizations. In the
pediatric cystic fibrosis population, there was improvement of lung function during
hospitalization and long term decrease in progression of lung disease. Furthermore, in
patients with mild to moderate asthma, there was no decline in lung function with the use of
beta agonist and HFCC versus beta agonist alone indicating good tolerance and safety.
Because asthma patients have mucus hypersecretion and this modality has been shown to be
effective in other patient populations with mucus hypersecretion, this modality can be used
as a means of reducing pulmonary morbidity and thereby allowing the respiratory therapist to
allocate his/her time more efficiently.
Purpose:
Assess efficacy of HFCC in PICU population ages 2 to 21 years of age with status asthmaticus
Design: Prospective Randomized non blinded HFCC (administered 4 times a day for 20 minutes)
with conventional PICU management of asthma exacerbation vs. conventional PICU management of
asthma exacerbation alone. Child would not have any of the standard asthma medications
changed or stopped because of this study.
End Points of Interest:
Primary
1) PICU days - Average number of PICU days as researched is about 4.47 days. There may be
factors such as non PICU floor availability and PICU rounds that may delay transfer from
PICU to the non PICU floor. So the official discharge from PICU will be when the attending
PICU physician announces or deems it acceptable for PICU discharge
Secondary
1. Length of hospitalization
2. Pediatric Asthma Severity Score a validated asthma severity score in pediatric
population: 1) observed level of respiratory distress 2) accessory muscle use 3)
auscultation (degree of wheezing) 4) oxygen saturation 5) respiratory rate Scored
observations 0, 1, or 2 and total the observation numbers for a Severity score
3. Discomfort
Patient inclusion 2 to 21 yo (VEST approved for over two yo) Admitted to PICU for status
asthmaticus Negative urine pregnancy test prior to initiation of study in those with menses
Patient Exclusion
Absolute contraindication to VEST use:
1. Unstable head or neck injury
2. Active hemorrhage with hemodynamic instability
3. Intracranial pressure > 20 mmHg or those in whom intracranial pressures should be
avoided (was a relative contraindication but after discussion moved to absolute)
Presence of anomalies such as:
1. Former premature infant with BPD
2. Congenital bronchogenic or pulmonary anomaly (i.e. CF)
3. Congenital heart disease
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment