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Pilot early noninvasive ventilation on all children who met the criteria was effective.
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Status asthmaticus is recognized as a common cause of morbidity in children in the United States. In recent years, hospitalization rates have reached an all time high. This study will evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive Pressure Ventilation (NPPV)to regular care in children with moderate to moderately severe status asthmaticus.
Status asthmaticus is defined as severe asthma that fails to respond to inhaled short acting β agonists (SABA), oral or intravenous steroids, and oxygen, leading to hospital admission for further management (1). In 2004, asthma exacerbations led to 3% (198,000) of all hospitalizations and 2.5 deaths per 1 million populations in the 0-17 year age group (2).
This prospective, unblinded, randomized controlled, pilot clinical trial will compare NPPV plus standard of care versus standard of care alone in children admitted for status asthmaticus. NPPV refers to the delivery of pressurized gas through an external interface such as a nasal or oronasal mask, connected to a pressure targeted ventilator. In other words, it provides ventilator support without the use of an endotracheal tube.
This study will investigate the safety, tolerability and efficacy of early initiation of non-invasive NPPV in pediatric patients admitted with status asthmaticus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPPV plus standard of care | Experimental | NPPV initiated early and for a prolonged period of time in addition to standard of care in the management of children admitted to the hospital with status asthmaticus |
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| Control: standard of care alone | No Intervention | standard of care in the management of children admitted to the hospital with status asthmaticus |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPPV plus standard of care | Other | Patients in the NPPV group were fitted with a nasal mask with gel seals (Comfortgel Masks, Respironics) and placed on the BiPAP Machine (Vision Bipap, Respironics). To optimize patient cooperation, the mask was initially applied manually to the patient's face. After a short adaptation period, it was firmly applied on the face by head straps to minimize air leak without causing skin injury. Pressures were initially set low for comfort and acceptance while being placed on the machine. The inspiratory positive airway pressure (IPAP) was gradually increased to 8 cm H2O in order to achieve a tidal volume of 6-9 ml/kg and the end expiratory positive airway pressure (EPAP) to 5 cm H 2O. These settings remained unchanged throughout the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical asthma score (CAS) | clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I&E ratio, retractions | initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate | determined by heart monitor | initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation |
| being able to wear the mask | Patient is able to keep the mask on for 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sangita Basnet, MD | Southern Illinois University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Illinois University School of Medicine | Springfield | Illinois | 62794-9676 | United States |
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| ID | Term |
|---|---|
| D013224 | Status Asthmaticus |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation |
| transcutaneous oxygen saturation | initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation |
| mental status | observation of activity level, agitation, etc. | initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation |
| supplemental oxygen | initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation |
| NPPV related side effects | NPPV related side effects could be minor including nasal bridge pain and skin irritation, gastric insufflations, sinus and ear pain, and dry eyes | initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |