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Non Invasive Positive Pressure Ventilation in Status Asthmaticus

This study has been withdrawn prior to enrollment.
(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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01403428
First Posted: July 27, 2011
Last Update Posted: December 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Southern Illinois University
  Purpose
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.

Condition Intervention Phase
Status Asthmaticus Other: Noninvasive positive pressure ventilation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect Of Early Initiation Of Noninvasive Positive Pressure Ventilation On ICU Length Of Stay In Children With Status Asthmaticus, A Prospective Randomized Trial

Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • length of stay [ Time Frame: baseline until transfer from PICU ]
    Number of hours patient hospitalized in PICU


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: June 2011
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
No Intervention: Standard of care
standard of care treatment in the management of children admitted to the hospital with status asthmaticus

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403428


Locations
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Sponsors and Collaborators
Southern Illinois University
Investigators
Principal Investigator: Sangita Basnet, MD Southern Illinois University School of Medicine
  More Information

Additional Information:
Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT01403428     History of Changes
Other Study ID Numbers: BAS-SIU-11-005
First Submitted: July 25, 2011
First Posted: July 27, 2011
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Southern Illinois University:
Asthma
non invasive ventilation
pediatrics
noninvasive positive pressure ventilation (NPPV)

Additional relevant MeSH terms:
Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases