Non Invasive Positive Pressure Ventilation in Status Asthmaticus
|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.|
|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Recruitment Status : Withdrawn (In a pilot of early noninvasive positive pressure ventilation, the children did so well that early NPPV is now used in all children who meet criteria.)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
|Condition or disease||Intervention/treatment||Phase|
|Status Asthmaticus||Other: Noninvasive positive pressure ventilation||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||March 2014|
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
- length of stay [ Time Frame: baseline until transfer from PICU ]Number of hours patient hospitalized in PICU
- 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
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
|United States, Illinois|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|Principal Investigator:||Sangita Basnet, MD||Southern Illinois University School of Medicine|