Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus - Full Text View

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.

Condition	Intervention	Phase
Status Asthmaticus	Other: NPPV plus standard of care	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Early Initiation of Noninvasive Positive Pressure Ventilation in Pediatric Patients Admitted With Status Asthmaticus

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Southern Illinois University:

Primary Outcome Measures:

clinical asthma score (CAS) [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ] [ Designated as safety issue: Yes ]
clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I&E ratio, retractions

Secondary Outcome Measures:

heart rate [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
mental status [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ] [ Designated as safety issue: No ]
observation of activity level, agitation, etc.
supplemental oxygen [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ] [ Designated as safety issue: Yes ]
NPPV related side effects [ Time Frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation ] [ Designated as safety issue: Yes ]
NPPV related side effects could be minor including nasal bridge pain and skin irritation, gastric insufflations, sinus and ear pain, and dry eyes

Enrollment:	20
Study Start Date:	January 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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. Other Names: Comfortgel Masks, Respironics Vision Bipap, Respironics
No Intervention: Control: standard of care alone standard of care in the management of children admitted to the hospital with status asthmaticus

Arms

Assigned Interventions

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.

Other Names:

Comfortgel Masks, Respironics
Vision Bipap, Respironics

No Intervention: Control: standard of care alone

standard of care in the management of children admitted to the hospital with status asthmaticus

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	1 Year to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188473

Locations

United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9676

Sponsors and Collaborators

Southern Illinois University

Investigators

Principal Investigator:

Sangita Basnet, MD

Southern Illinois University School of Medicine

More Information

No publications provided

Responsible Party:	Sangita Basnet, MD, Assistant Professor, Southern Illinois University School of Medicine
ClinicalTrials.gov Identifier:	NCT01188473 History of Changes
Other Study ID Numbers:	BAS-SIU-10-005
Study First Received:	August 23, 2010
Last Updated:	August 23, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Southern Illinois University:

Status Asthmaticus
Noninvasive Positive Pressure Ventilation
Asthma in Children

Additional relevant MeSH terms:

Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013