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Use of High Frequency Chest Compression in Pediatric Status Asthmaticus
This study is currently recruiting participants.
Study NCT00552448   Information provided by Texas Tech University Health Sciences Center
First Received: November 1, 2007   Last Updated: December 11, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

November 1, 2007
December 11, 2008
October 2007
PICU stay [ Time Frame: days/hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00552448 on ClinicalTrials.gov Archive Site
 
 
 
Use of High Frequency Chest Compression in Pediatric Status Asthmaticus
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. We propose that using this device in our pediatric patients hospitalized in the pediatric ICU with asthma will result in decreased pediatric ICU stay. We 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
 
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Status Asthmaticus, Pediatric
Device: High Frequency Chest Compression VEST
  • Experimental: Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
  • No Intervention: This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
37
October 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
2 Years to 21 Years
No
Contact: Adaobi C Kanu, MD 806 743 2244 ext 249 adaobi.kanu@ttuhsc.edu
Contact: Myrtha Gregoire, MD 631 444 8340 mgregoire@notes.cc.sunysb.edu
United States
 
 
NCT00552448
Adaobi Kanu, MD, Texas Tech University Health Sciences Center
 
Texas Tech University Health Sciences Center
 
Principal Investigator: Adaobi C Kanu, MD Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
December 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.