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Non Invasive Positive Pressure Ventilation in Status Asthmaticus

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ClinicalTrials.gov Identifier: NCT01403428
Recruitment Status : Withdrawn (In a pilot of early noninvasive positive pressure ventilation, the children did so well that early NPPV is now used in all children who meet criteria.)
First Posted : July 27, 2011
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date December 12, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
length of stay [ Time Frame: baseline until transfer from PICU ]
Number of hours patient hospitalized in PICU
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • clinical asthma score [ Time Frame: baseline until transfer from PICU ]
    Clinical asthma score (CAS) will be recorded in 2 hour segments by clinical evaluation of 5 items—respiratory rate, inspiratory-expiratory ratio, retractions, adequacy of air exchange and wheezing—on a 3-point scale. A higher score indicates worsening respiratory status.
  • tolerability [ Time Frame: baseline until transfer from PICU ]
    Number of hours patient able to wear the NPPV mask will be recorded in 2 hour segments.
  • patient care costs [ Time Frame: baseline until transfer from PICU ]
    Actual costs accrued during PICU stay.
  • safety [ Time Frame: baseline until transfer from PICU ]
    measure of clinical monitoring parameters:
    • Respiratory rate
    • pH
    • PaCO2
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non Invasive Positive Pressure Ventilation in Status Asthmaticus
Official Title  ICMJE Effect Of Early Initiation Of Noninvasive Positive Pressure Ventilation On ICU Length Of Stay In Children With Status Asthmaticus, A Prospective Randomized Trial
Brief Summary Status Asthmaticus is recognized as a common cause of morbidity in children in the United States (CDC). In recent years, hospitalization rates have reached an all time high. This study will evaluate the effect of early use of noninvasive positive pressure ventilation (NPPV) in children admitted to the pediatric intensive care unit (PICU) with moderate to moderately severe status asthmaticus to test the hypothesis that early initiation of NPPV plus standard of care will result in decreased length of PICU stay, significant improvement in clinical asthma score (CAS) and reduced patient care costs when compared to standard of care alone.
Detailed Description

Asthma is a common, chronic and complex disorder of the airways, with symptoms that are variable and recurring. It is characterized by bronchial hyper-responsiveness to various stimuli, airflow obstruction that is often reversible, and underlying inflammation. Conventional therapy for status asthmaticus is directed at relieving broncho-constriction, decreasing airway inflammation and clearing airway mucus. However, in some patients, maximal standard therapies are inadequate and can lead to prolonged hospitalization. Intubation and mechanical ventilation in patients with asthma is associated with significant risks. NPPV has several advantages over invasive intubation and mechanical ventilation. It leaves the upper airway intact, and avoids the risks associated with endotracheal intubation including upper airway trauma, laryngeal swelling, postextubation vocal cord dysfunction, and nosocomial infections.

This study will be a prospective, open-labeled, randomized clinical trial comparing the use of NPPV plus standard of care versus standard of care alone in children admitted for status asthmaticus. A simple random numbers table will be used to assign subjects to either the NPPV plus standard of care group or standard of care alone group. In the first hour, all patients in both groups will receive a 2mg/kg dose of systemic steroid, continuous albuterol at 0.5mg/kg/hr (max of 15mg/hr) with 3 doses of 0.25-0.5 mg nebulized ipratropium bromide, and supplemental oxygen keep saturation >92%. Patients on both therapeutic arms will continue to receive 2mg/kg dose of systemic steroid per day, continuous albuterol at 0.5mg/kg/hr (max of 15mg/hr) and supplemental oxygen to keep saturation >92%.

Patients randomized to the NPPV plus standard of care group will be fitted with a nasal or face mask and placed on the Respironics V60 bilevel positive airway pressure (BiPAP) Ventilator 33. Masks with gel seals at different pressure points will be used to prevent skin breakdown. To optimize patient cooperation, the mask will initially be applied manually to the patient's face. After a short adaptation period for the patient to feel comfortable, the mask will be firmly applied with head straps to minimize air leak without causing skin injury. Pressures will initially be low for comfort and acceptance while being placed on the machine.

Patients randomized to the standard of care group will be placed on a similar continuous nebulizer attached to a similar oxygen blender as the ones used with the V60 unit set-up, using the same liter flow (11 liters per minute). An aerosol mask will be placed on the patient to aid in the delivery of the medication. The oxygen will be analyzed at the site of this mask with the initial set-up and any time the oxygen is decreased or increased.

Data will be collected at baseline as soon as the patient is enrolled in the study. It will include: demographic variables, medical record number, age, race, gender; history and physical findings, other medical conditions, vital signs, oxygen saturation at baseline, CAS, peak flow in children >6 years of age, asthma severity prior to admission, NPPV settings, length of stay in the PICU, side effect profiles (tremor, tachycardia, agitation, nausea, nasal bridge pain, skin irritation/ulceration, gastric distension, dry eyes/mucosal dryness, sinus/ear pain, aspiration pneumonia, hypotension and pneumothorax).

Each child's participation in the study will end when the child is transferred from the PICU.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Status Asthmaticus
Intervention  ICMJE Other: Noninvasive positive pressure ventilation
Noninvasive positive pressure ventilation (NPPV) will deliver pressurized gas through a nasal or oronasal mask, connected to a pressure targeted ventilator. NPPV provides ventilator support without the use of an endotracheal tube. Standard of care includes use of corticosteroids, oxygen, short acting β-agonist and inhaled ipratropium bromide.
Study Arms  ICMJE
  • Experimental: NPPV plus standard of care
    Noninvasive positive pressure ventilation (NPPV) plus standard of care in the management of children admitted to the hospital with status asthmaticus
    Intervention: Other: Noninvasive positive pressure ventilation
  • No Intervention: Standard of care
    standard of care treatment in the management of children admitted to the hospital with status asthmaticus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 5, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2011)
60
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1-18 years old
  • Known H/O asthma
  • With status asthmaticus
  • CAS score 2-8 after one dose of systemic steroid, 1 hour of continuous albuterol and 3 doses of ipratropium bromide.

Exclusion Criteria:

  • No previous history of asthma.
  • Absence of airway protective reflexes.
  • Absence of respiratory drive.
  • Problems with clearing 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.
  • Discretion of the attending physician depending on the severity of illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403428
Other Study ID Numbers  ICMJE BAS-SIU-11-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southern Illinois University
Study Sponsor  ICMJE Southern Illinois University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sangita Basnet, MD Southern Illinois University School of Medicine
PRS Account Southern Illinois University
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP