Use of High Frequency Chest Compression in Pediatric Status Asthmaticus
Primary Purpose
Pediatric, Asthma, Acute Exacerbation, Pediatric ICU
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Frequency Chest Compression VEST
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric, Asthma, Acute Exacerbation, Pediatric ICU focused on measuring Pediatric, asthma, pediatric ICU
Eligibility 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
Sites / Locations
- Stony Brook University Medical Center
- Spartanburg Regional Medical Center
- Texas Tech University Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
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.
Outcomes
Primary Outcome Measures
Hours Spent in Pediatric ICU
Length of stay (hours) in Pediatric ICU.
Secondary Outcome Measures
Total Days of Hospital Admission
This is limited due to non collection by collaborating centers.
Pediatric Asthma Severity Score (Modified Pulmonary Index Score)
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
Full Information
NCT ID
NCT00552448
First Posted
November 1, 2007
Last Updated
September 12, 2016
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT00552448
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Continuing review not submitted to IRB within 365 days.
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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. 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.
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
Length of hospitalization
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
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric, Asthma, Acute Exacerbation, Pediatric ICU
Keywords
Pediatric, asthma, pediatric ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Frequency Chest Compression VEST
Intervention Description
every 6 hours for 20 minutes
Primary Outcome Measure Information:
Title
Hours Spent in Pediatric ICU
Description
Length of stay (hours) in Pediatric ICU.
Time Frame
Number of hours from admission to discharge from PICU
Secondary Outcome Measure Information:
Title
Total Days of Hospital Admission
Description
This is limited due to non collection by collaborating centers.
Time Frame
Days
Title
Pediatric Asthma Severity Score (Modified Pulmonary Index Score)
Description
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
Time Frame
Discharge from PICU
Title
Number of Participants With Chest Discomfort
Time Frame
During PICU admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adaobi C Kanu, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Use of High Frequency Chest Compression in Pediatric Status Asthmaticus
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