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Tracking Information | |||||||||
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First Received Date † | November 1, 2007 | ||||||||
Last Updated Date | December 11, 2008 | ||||||||
Start Date † | October 2007 | ||||||||
Current Primary Outcome Measures † |
PICU stay [ Time Frame: days/hours ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00552448 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Use of High Frequency Chest Compression in Pediatric Status Asthmaticus | ||||||||
Official Title † | Use of High Frequency Chest Compression (HFCC) in Pediatric Status Asthmaticus | ||||||||
Brief Summary | 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. |
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Detailed Description | 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
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:
Presence of anomalies such as:
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Study Phase | |||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study | ||||||||
Condition † | Status Asthmaticus, Pediatric | ||||||||
Intervention † | Device: High Frequency Chest Compression VEST | ||||||||
Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 37 | ||||||||
Estimated Completion Date | October 2010 | ||||||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Presence of anomalies such as:
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Gender | Both | ||||||||
Ages | 2 Years to 21 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00552448 | ||||||||
Responsible Party | Adaobi Kanu, MD, Texas Tech University Health Sciences Center | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Texas Tech University Health Sciences Center | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | Texas Tech University Health Sciences Center | ||||||||
Verification Date | December 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |