Use of High Frequency Chest Compression in Pediatric Status Asthmaticus

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Texas Tech University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00552448
First received: November 1, 2007
Last updated: March 26, 2014
Last verified: March 2014
  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 2015
Estimated Primary Completion Date: December 2014 (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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 26, 2014
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 August 01, 2014