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Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus

Primary Purpose

Status Asthmaticus

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NPPV plus standard of care
Sponsored by
Southern Illinois University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Asthmaticus focused on measuring Status Asthmaticus, Noninvasive Positive Pressure Ventilation, Asthma in Children

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Illinois University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NPPV plus standard of care

Control: standard of care alone

Arm 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

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

Outcomes

Primary Outcome Measures

clinical asthma score (CAS)
clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I&E ratio, retractions

Secondary Outcome Measures

heart rate
determined by heart monitor
being able to wear the mask
Patient is able to keep the mask on for 24 hours.
transcutaneous oxygen saturation
mental status
observation of activity level, agitation, etc.
supplemental oxygen
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

Full Information

First Posted
August 23, 2010
Last Updated
December 18, 2014
Sponsor
Southern Illinois University
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1. Study Identification

Unique Protocol Identification Number
NCT01188473
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Pilot early noninvasive ventilation on all children who met the criteria was effective.
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Illinois University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Asthmaticus
Keywords
Status Asthmaticus, Noninvasive Positive Pressure Ventilation, Asthma in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPPV plus standard of care
Arm Type
Experimental
Arm 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
Arm Title
Control: standard of care alone
Arm Type
No Intervention
Arm Description
standard of care in the management of children admitted to the hospital with status asthmaticus
Intervention Type
Other
Intervention Name(s)
NPPV plus standard of care
Other Intervention Name(s)
Comfortgel Masks, Respironics, Vision Bipap, Respironics
Intervention 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 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.
Primary Outcome Measure Information:
Title
clinical asthma score (CAS)
Description
clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I&E ratio, retractions
Time Frame
initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Secondary Outcome Measure Information:
Title
heart rate
Description
determined by heart monitor
Time Frame
initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Title
being able to wear the mask
Description
Patient is able to keep the mask on for 24 hours.
Time Frame
initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Title
transcutaneous oxygen saturation
Time Frame
initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Title
mental status
Description
observation of activity level, agitation, etc.
Time Frame
initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Title
supplemental oxygen
Time Frame
initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Title
NPPV related side effects
Description
NPPV related side effects could be minor including nasal bridge pain and skin irritation, gastric insufflations, sinus and ear pain, and dry eyes
Time Frame
initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangita Basnet, MD
Organizational Affiliation
Southern Illinois University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9676
Country
United States

12. IPD Sharing Statement

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Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus

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