Expired Study
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Springfield, Illinois 62794


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - children, 1- 18 years of age, with a known history of asthma admitted to the PICU at St John's Children's Hospital with status asthmaticus - clinical asthma score (CAS) between 3 - 8 after receiving one dose of systemic steroid, 1 hour of continuous albuterol (SABA), and 3 doses of ipratropium bromide - written informed consent from the patient's parent or legal guardian Exclusion Criteria: - no previous history of asthma, - absence of airway protective reflexes, - absence of respiratory drive, - excessive oral secretions, - need for emergent intubation as determined by the attending physician, - facial or airway anomaly or injury precluding the use of tight fitting mask


Study is Available At:


Original ID:

BAS-SIU-10-005


NCT ID:

NCT01188473


Secondary ID:


Study Acronym:


Brief Title:

Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus


Official Title:

Safety and Efficacy of Early Initiation of Noninvasive Positive Pressure Ventilation in Pediatric Patients Admitted With Status Asthmaticus


Overall Status:

Withdrawn


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

1 Year


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southern Illinois University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Pilot early noninvasive ventilation on all c


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sangita Basnet, MD
Principal Investigator
Southern Illinois University School of Medicine

Study Dates

Start Date:January 2009
Completion Date:January 2010
Completion Type:Actual
Primary Completion Date:January 2010
Primary Completion Type:Actual
Verification Date:December 2014
Last Changed Date:December 18, 2014
First Received Date:August 23, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:clinical asthma score (CAS)
Time Frame:initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Safety Issues:True
Description:clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I&E ratio, retractions
Outcome Type:Secondary Outcome
Measure:heart rate
Time Frame:initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Safety Issues:True
Description:determined by heart monitor
Outcome Type:Secondary Outcome
Measure:being able to wear the mask
Time Frame:initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Safety Issues:False
Description:Patient is able to keep the mask on for 24 hours.
Outcome Type:Secondary Outcome
Measure:transcutaneous oxygen saturation
Time Frame:initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:mental status
Time Frame:initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Safety Issues:False
Description:observation of activity level, agitation, etc.
Outcome Type:Secondary Outcome
Measure:supplemental oxygen
Time Frame:initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:NPPV related side effects
Time Frame:initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Safety Issues:True
Description:NPPV related side effects could be minor including nasal bridge pain and skin irritation, gastric insufflations, sinus and ear pain, and dry eyes

Study Interventions

Intervention Type:Other
Name:NPPV plus standard of care
Description: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 inspirat
Arm Name:NPPV plus standard of care
Other Name:Comfortgel Masks, Respironics

Study Arms

Study Arm Type:No Intervention
Arm Name:Control: standard of care alone
Description:standard of care in the management of children admitted to the hospital with status asthmaticus
Study Arm Type:Experimental
Arm Name:NPPV plus standard of care
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southern Illinois University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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