Status Asthmaticus
Conditions
Keywords
Status asthmaticus, Asthma, Helium, Children
Brief summary
The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.
Detailed description
We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, I/E ratio, and accessory muscle use). Scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. All scoring using the CAS will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. All children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation \>90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. After written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique: Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox. Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.
Interventions
DRUGHelium-oxygen-driven albuterol nebulizer
Subjects will be treated with continuous albuterol nebs with Heliox
DRUGOxygen
Subjects will be treated with continuous albuterol nebs in oxygen
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 2 -18 years; * Previous history of asthma; * Hospital admission for acute asthma exacerbation; * Clinical asthma score greater than or equal to 3
Exclusion criteria
* Less than 2 years old or over 18 years old; * Known allergy or hypersensitivity to ß-agonists; * Require mechanical ventilation (invasive or non-invasive); * Require FiO2 \>0.4; * Failure to obtain informed consent; * Enrollment in another investigational drug or asthma protocol; * Incipient respiratory failure including but limited to respiratory acidosis(pCO2\>60 torr), altered mental status and/or excessive work of breathing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Hospital discharge | Time to discharge eligibility (hours) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Heliox Group Patients randomized to the Heliox arm of the study | 22 |
| Control Group Subjects randomized to the control arm of the study | 20 |
| Total | 42 |
Baseline characteristics
| Characteristic | Control Group | Heliox Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 22 Participants | 42 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 8.2 years STANDARD_DEVIATION 0.9 | 7.3 years STANDARD_DEVIATION 0.8 | 7.8 years STANDARD_DEVIATION 0.8 |
| Region of Enrollment United States | 20 participants | 22 participants | 42 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 |
Outcome results
Primary
Length of Stay
Time to discharge eligibility (hours)
Time frame: Hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heliox Group | Length of Stay | 66.2 hours | Standard Error 8.7 |
| Control Group | Length of Stay | 63.4 hours | Standard Error 8.6 |