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Use of High Frequency Chest Compression in Pediatric Status Asthmaticus

This study has been terminated.
(Continuing review not submitted to IRB within 365 days.)
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00552448
First received: November 1, 2007
Last updated: September 12, 2016
Last verified: September 2016
  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
Pediatric, Asthma, Acute Exacerbation, Pediatric ICU
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

Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Hours Spent in Pediatric ICU [ Time Frame: Number of hours from admission to discharge from PICU ] [ Designated as safety issue: Yes ]
    Length of stay (hours) in Pediatric ICU.


Secondary Outcome Measures:
  • Total Days of Hospital Admission [ Time Frame: Days ] [ Designated as safety issue: No ]
    This is limited due to non collection by collaborating centers.

  • Pediatric Asthma Severity Score (Modified Pulmonary Index Score) [ Time Frame: Discharge from PICU ] [ Designated as safety issue: No ]
    Modified Pulmonary Index Score (MPIS): a validated asthma severity score in pediatric population (Carroll CL et al. A modified pulmonary index score with predictive value for pediatric asthma exacerbations, Ann Allergy Asthma Immunol 2005) Consists of: 1) oxygen saturation on room air 2) accessory muscle use 3) inspiratory to expiratory ratio 4) degree of wheezing 5) heart rate 6) respiratory rate Scored observations 0, 1, 2 or 3. Total score range 0 - 18. Mild exacerbation total less than 6, moderate exacerbation 6 - 10, severe exacerbation higher than 10

  • Number of Participants With Chest Discomfort [ Time Frame: During PICU admission ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: October 2007
Study Completion Date: September 2014
Primary Completion Date: July 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   (Child, Adult)
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

Locations
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Texas Tech University Health Sciences Center
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

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
Results First Received: July 7, 2016
Last Updated: September 12, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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 September 30, 2016