Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus

Status Asthmaticus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01188473
• Other study ID #: BAS-SIU-10-005
• Status: Withdrawn
• Phase: Phase 1
• First received: August 23, 2010
• Last updated: December 18, 2014
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: December 2014
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Status Asthmaticus

Intervention

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.

Locations

Country	Name	City	State
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Southern Illinois University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	heart rate	determined by heart monitor	initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation	Yes
Secondary	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	No
Secondary	transcutaneous oxygen saturation		initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation	Yes
Secondary	mental status	observation of activity level, agitation, etc.	initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation	No
Secondary	supplemental oxygen		initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation	Yes
Secondary	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	Yes