Use of High Frequency Chest Compression in Pediatric Status Asthmaticus
This study is currently recruiting participants.
Verified December 2012 by Texas Tech University Health Sciences Center
Sponsor:
Texas Tech University Health Sciences Center
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00552448
First received: November 1, 2007
Last updated: December 14, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Status Asthmaticus, Pediatric |
Device: High Frequency Chest Compression VEST |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Use of High Frequency Chest Compression (HFCC) in Pediatric Status Asthmaticus |
Resource links provided by NLM:
Further study details as provided by Texas Tech University Health Sciences Center:
Primary Outcome Measures:
- PICU stay [ Time Frame: days/hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 37 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
|
Device: High Frequency Chest Compression VEST
every 6 hours for 20 minutes
|
|
No Intervention: 2
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- Unstable head or neck injury
- Active hemorrhage with hemodynamic instability
- 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:
- Former premature infant with BPD
- Congenital bronchogenic or pulmonary anomaly (i.e. CF)
- Congenital heart disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552448
Contacts
| 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 |
Locations
| United States, New York | |
| Stony Brook University Medical Center | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| United States, South Carolina | |
| Spartanburg Regional Medical Center | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Hanna Sahhar, MD | |
| Contact: Devonne Gerstenacker, RN BSN (864) 560-6426 ext 66426 dgerstenacker@srhs.com | |
| United States, Texas | |
| Texas Tech University Health Sciences Center | Active, not recruiting |
| Lubbock, Texas, United States, 79430 | |
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
| Principal Investigator: | Adaobi C Kanu, MD | Texas Tech University Health Sciences Center |
More Information
No publications provided
| Responsible Party: | Texas Tech University Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00552448 History of Changes |
| Other Study ID Numbers: | 20076812 |
| Study First Received: | November 1, 2007 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Tech University Health Sciences Center:
|
Pediatric, asthma, pediatric ICU |
Additional relevant MeSH terms:
|
Status Asthmaticus Asthma Bronchial Diseases Respiratory Tract Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013