Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus

NCT01188473 | Withdrawn Phase 1

• 1 other identifier: BAS-SIU-10-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Status Asthmaticus

Keywords

Status Asthmaticus; Noninvasive Positive Pressure Ventilation; Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• heart rate

  initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation

• being able to wear the mask

  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

  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

Study Arms (2)

NPPV plus standard of care

EXPERIMENTAL

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

Control: standard of care alone

NO INTERVENTION

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

Interventions

NPPV plus standard of care OTHER

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.

Also known as: Comfortgel Masks, Respironics, Vision Bipap, Respironics

NPPV plus standard of care

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9676, United States

Location

MeSH Terms

Conditions

Status Asthmaticus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sangita Basnet, MD

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 25, 2010
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (1)