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Use of High Frequency Chest Compression in Pediatric Status Asthmaticus

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00552448
Enrollment
36
Registered
2007-11-02
Start date
2007-10-31
Completion date
2014-09-30
Last updated
2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric, Asthma, Acute Exacerbation, Pediatric ICU

Keywords

Pediatric, asthma, pediatric ICU

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 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

Interventions

DEVICEHigh Frequency Chest Compression VEST

every 6 hours for 20 minutes

Sponsors

Texas Tech University Health Sciences Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hours Spent in Pediatric ICUNumber of hours from admission to discharge from PICULength of stay (hours) in Pediatric ICU.

Secondary

MeasureTime frameDescription
Total Days of Hospital AdmissionDaysThis is limited due to non collection by collaborating centers.
Pediatric Asthma Severity Score (Modified Pulmonary Index Score)Discharge from PICUModified 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 DiscomfortDuring PICU admission

Countries

United States

Participant flow

Participants by arm

ArmCount
Pediatric Status Asthmatics Patients on HFCC Device
Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received High Frequency Chest Compression VEST: every 6 hours for 20 minutes
20
Pediatric Status Asthmaticus Patients Not Using HFCC
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.
16
Total36

Baseline characteristics

CharacteristicPediatric Status Asthmatics Patients on HFCC DevicePediatric Status Asthmaticus Patients Not Using HFCCTotal
Age, Continuous5.95 years
STANDARD_DEVIATION 3.53
6.69 years
STANDARD_DEVIATION 3.93
6.28 years
STANDARD_DEVIATION 3.68
Home asthma medication
Antihistamine
3 participants2 participants5 participants
Home asthma medication
Bronchodilator alone
8 participants7 participants15 participants
Home asthma medication
Inhaled steroid
5 participants3 participants8 participants
Home asthma medication
Inhaled steroid-long acting bronchodilator
4 participants1 participants5 participants
Home asthma medication
leukotriene receptor antagonist
6 participants5 participants11 participants
Home asthma medication
None
1 participants2 participants3 participants
Home asthma medication
Systemic steroid
2 participants0 participants2 participants
Modified Pulmonary Index Score (Initial)5.76 units on a scale
STANDARD_DEVIATION 2.91
6.42 units on a scale
STANDARD_DEVIATION 2.91
6.03 units on a scale
STANDARD_DEVIATION 2.87
Prior Hospitalizations
None
8 participants8 participants16 participants
Prior Hospitalizations
Unknown
1 participants0 participants1 participants
Prior Hospitalizations
Yes
11 participants8 participants19 participants
Race/Ethnicity, Customized
Black or African American
9 participants9 participants18 participants
Race/Ethnicity, Customized
Caucasian
9 participants2 participants11 participants
Race/Ethnicity, Customized
Ethnicity/Race Unknown
0 participants2 participants2 participants
Race/Ethnicity, Customized
Hispanic or Latino
1 participants2 participants3 participants
Race/Ethnicity, Customized
Two or more Ethnicity/Races
1 participants1 participants2 participants
Region of Enrollment
United States
20 participants16 participants36 participants
Sex: Female, Male
Female
9 Participants9 Participants18 Participants
Sex: Female, Male
Male
11 Participants7 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 200 / 16
serious
Total, serious adverse events
0 / 200 / 16

Outcome results

Primary

Hours Spent in Pediatric ICU

Length of stay (hours) in Pediatric ICU.

Time frame: Number of hours from admission to discharge from PICU

ArmMeasureValue (MEAN)Dispersion
Pediatric Status Asthmatics Patients on HFCC DeviceHours Spent in Pediatric ICU23.71 HoursStandard Deviation 8.33
Pediatric Status Asthmaticus Patients Not Using HFCCHours Spent in Pediatric ICU23.76 HoursStandard Deviation 12.24
Secondary

Number of Participants With Chest Discomfort

Time frame: During PICU admission

ArmMeasureValue (NUMBER)
Pediatric Status Asthmatics Patients on HFCC DeviceNumber of Participants With Chest Discomfort3 participants
Pediatric Status Asthmaticus Patients Not Using HFCCNumber of Participants With Chest Discomfort0 participants
Secondary

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

Time frame: Discharge from PICU

Population: Participants with available data

ArmMeasureValue (MEAN)
Pediatric Status Asthmatics Patients on HFCC DevicePediatric Asthma Severity Score (Modified Pulmonary Index Score)1.88 units on a scale
Pediatric Status Asthmaticus Patients Not Using HFCCPediatric Asthma Severity Score (Modified Pulmonary Index Score)1.9 units on a scale
Secondary

Total Days of Hospital Admission

This is limited due to non collection by collaborating centers.

Time frame: Days

Population: Data not collected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026