Pediatric, Asthma, Acute Exacerbation, Pediatric ICU
Conditions
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
every 6 hours for 20 minutes
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Hours Spent in Pediatric ICU | Number of hours from admission to discharge from PICU | Length of stay (hours) in Pediatric ICU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Days of Hospital Admission | Days | This is limited due to non collection by collaborating centers. |
| Pediatric Asthma Severity Score (Modified Pulmonary Index Score) | Discharge from PICU | 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 | During PICU admission | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 36 |
Baseline characteristics
| Characteristic | Pediatric Status Asthmatics Patients on HFCC Device | Pediatric Status Asthmaticus Patients Not Using HFCC | Total |
|---|---|---|---|
| Age, Continuous | 5.95 years STANDARD_DEVIATION 3.53 | 6.69 years STANDARD_DEVIATION 3.93 | 6.28 years STANDARD_DEVIATION 3.68 |
| Home asthma medication Antihistamine | 3 participants | 2 participants | 5 participants |
| Home asthma medication Bronchodilator alone | 8 participants | 7 participants | 15 participants |
| Home asthma medication Inhaled steroid | 5 participants | 3 participants | 8 participants |
| Home asthma medication Inhaled steroid-long acting bronchodilator | 4 participants | 1 participants | 5 participants |
| Home asthma medication leukotriene receptor antagonist | 6 participants | 5 participants | 11 participants |
| Home asthma medication None | 1 participants | 2 participants | 3 participants |
| Home asthma medication Systemic steroid | 2 participants | 0 participants | 2 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 participants | 8 participants | 16 participants |
| Prior Hospitalizations Unknown | 1 participants | 0 participants | 1 participants |
| Prior Hospitalizations Yes | 11 participants | 8 participants | 19 participants |
| Race/Ethnicity, Customized Black or African American | 9 participants | 9 participants | 18 participants |
| Race/Ethnicity, Customized Caucasian | 9 participants | 2 participants | 11 participants |
| Race/Ethnicity, Customized Ethnicity/Race Unknown | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Two or more Ethnicity/Races | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 20 participants | 16 participants | 36 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 20 | 0 / 16 |
| serious Total, serious adverse events | 0 / 20 | 0 / 16 |
Outcome results
Hours Spent in Pediatric ICU
Length of stay (hours) in Pediatric ICU.
Time frame: Number of hours from admission to discharge from PICU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pediatric Status Asthmatics Patients on HFCC Device | Hours Spent in Pediatric ICU | 23.71 Hours | Standard Deviation 8.33 |
| Pediatric Status Asthmaticus Patients Not Using HFCC | Hours Spent in Pediatric ICU | 23.76 Hours | Standard Deviation 12.24 |
Number of Participants With Chest Discomfort
Time frame: During PICU admission
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric Status Asthmatics Patients on HFCC Device | Number of Participants With Chest Discomfort | 3 participants |
| Pediatric Status Asthmaticus Patients Not Using HFCC | Number of Participants With Chest Discomfort | 0 participants |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pediatric Status Asthmatics Patients on HFCC Device | Pediatric Asthma Severity Score (Modified Pulmonary Index Score) | 1.88 units on a scale |
| Pediatric Status Asthmaticus Patients Not Using HFCC | Pediatric Asthma Severity Score (Modified Pulmonary Index Score) | 1.9 units on a scale |
Total Days of Hospital Admission
This is limited due to non collection by collaborating centers.
Time frame: Days
Population: Data not collected