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Pediatric, Asthma, Acute Exacerbation, Pediatric ICUNCT00552448

Use of High Frequency Chest Compression in Pediatric Status Asthmaticus

A study testing High Frequency Chest Compression VEST in people with Pediatric, Asthma, Acute Exacerbation, Pediatric ICU, run by Texas Tech University Health Sciences Center at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 21 years
What is being tested?
High Frequency Chest Compression VEST
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesUnited States
Study dates
Oct 2007to Sep 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: Use of High Frequency Chest Compression (HFCC) in Pediatric Status Asthmaticus

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.

Read the 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

  1. Length of hospitalization
  2. 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
  3. 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:

  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
Being tested
High Frequency Chest Compression VEST
Keywords
Pediatric, asthma, pediatric ICU
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Frequency Chest Compression VESTDevice

    every 6 hours for 20 minutes

Study groups in NCT00552448
Study groupRoleWhat they receive
1ExperimentalUse of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received
Receives: Device: High Frequency Chest Compression VEST
2No interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hours Spent in Pediatric ICU

    Length of stay (hours) in Pediatric ICU.

    Measured: Number of hours from admission to discharge from PICU

Secondary outcomes (3)
  1. Total Days of Hospital Admission

    This is limited due to non collection by collaborating centers.

    Measured: Days

  2. 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

    Measured: Discharge from PICU

  3. Number of Participants With Chest Discomfort

    Measured: During PICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2014
  4. Study completionSep 2014

Why it stopped: Continuing review not submitted to IRB within 365 days.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00552448
Sponsor's protocol ID
20076812
Status last verified
Sep 2016
First submitted
1 Nov 2007
Last updated
14 Sep 2016
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing High Frequency Chest Compression VEST in people with Pediatric, Asthma, Acute Exacerbation, Pediatric ICU, run by Texas Tech University Health Sciences Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hours Spent in Pediatric ICU (time frame: Number of hours from admission to discharge from PICU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.

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