Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus
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|ClinicalTrials.gov Identifier: NCT01188473|
Recruitment Status : Withdrawn (Pilot early noninvasive ventilation on all children who met the criteria was effective.)
First Posted : August 25, 2010
Last Update Posted : December 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Status Asthmaticus||Other: NPPV plus standard of care||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Early Initiation of Noninvasive Positive Pressure Ventilation in Pediatric Patients Admitted With Status Asthmaticus|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Experimental: NPPV plus standard of care
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
Other: NPPV plus standard of care
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.
No Intervention: Control: standard of care alone
standard of care in the management of children admitted to the hospital with status asthmaticus
- clinical asthma score (CAS) [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ]clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I&E ratio, retractions
- heart rate [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ]determined by heart monitor
- being able to wear the mask [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ]Patient is able to keep the mask on for 24 hours.
- transcutaneous oxygen saturation [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ]
- mental status [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ]observation of activity level, agitation, etc.
- supplemental oxygen [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ]
- NPPV related side effects [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ]NPPV related side effects could be minor including nasal bridge pain and skin irritation, gastric insufflations, sinus and ear pain, and dry eyes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188473
|United States, Illinois|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62794-9676|
|Principal Investigator:||Sangita Basnet, MD||Southern Illinois University School of Medicine|