Non Invasive Positive Pressure Ventilation in Status Asthmaticus

This study has suspended participant recruitment.
(Research Coordinator is being replaced.)
Sponsor:
Information provided by (Responsible Party):
Dr. Sangita Basnet, Southern Illinois University
ClinicalTrials.gov Identifier:
NCT01403428
First received: July 25, 2011
Last updated: July 26, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • length of stay [ Time Frame: baseline until transfer from PICU ] [ Designated as safety issue: No ]
    Number of hours patient hospitalized in PICU


Secondary Outcome Measures:
  • clinical asthma score [ Time Frame: baseline until transfer from PICU ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Actual costs accrued during PICU stay.

  • safety [ Time Frame: baseline until transfer from PICU ] [ Designated as safety issue: Yes ]

    measure of clinical monitoring parameters:

    • Respiratory rate
    • pH
    • PaCO2


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Dr. Sangita Basnet, Assitant Professor, Department of Pediatrics, Southern Illinois University
ClinicalTrials.gov Identifier: NCT01403428     History of Changes
Other Study ID Numbers: BAS-SIU-11-005
Study First Received: July 25, 2011
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014