Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus

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

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 Overview

• Status: Withdrawn
• Conditions: Status Asthmaticus
• Intervention / Treatment: Other: NPPV plus standard of care

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Southern Illinois University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 25, 2010

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Noninvasive Positive Pressure Ventilation; Asthma in Children; Status Asthmaticus
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Status Asthmaticus
• Other Study ID Numbers: BAS-SIU-10-005