Non-invasive Ventilation vs. Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma
NCT ID: NCT03296579
Last Updated: 2018-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-06-30
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non Invasive Positive Pressure Ventilation in Status Asthmaticus
NCT01403428
High Flow Nasal Cannula in Children With Status Asthmaticus
NCT03157102
Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
NCT01497691
Breath-Actuated Nebulizer Versus Conventional Continuous-Output Nebulizer in Pediatric Asthma Patients
NCT01045174
NIV Application in the Treatment of Asthmatic Children
NCT02939625
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The principal enrollment criteria will be children over 2 years of age presenting to the ER with acute asthma. After diagnosis, all children are treated with standard therapy (systemic steroids plus 3 doses of inhaled salbutamol and 1 dose of inhaled ipratropium over a 1 hour period then hourly salbutamol). The principal decision between discharge track and admission track will be made at 2 hours after first steroid dose. Admission criteria are based on sequential PRAM scores.
After initial asthma treatment and observation in the emergency room, to determine which patients can be discharged home, those who need admission will be asked to join the study, then consented and randomized. There will be three treatment groups:
* BiPAP: standard steroid dose, hourly salbutamol and BiPAP at 15/5 cm H2O by face mask with rate 10 to 15/min, oxygen as needed.
* CPAP: standard steroid dose, hourly salbutamol and 8 to 10 cm H2O constant pressure by face mask, oxygen as needed.
* Conventional therapy: standard steroid dose plus hourly nebulized salbutamol, nebulized ipratropium q 6 hrly, magnesium sulphate 50 mg/kg IV (4 doses q 6 hrly), loading dose of aminophylline 6 mg/kg IV if no progress, oxygen as needed.
All children will be admitted to a small 3 bed respiratory unit. They will be closely monitored and objectively scored every 4 hours using the PRAM asthma clinical severity score (Pediatric Respiratory Assessment Measure). Projected patient enrollment will be at least 30 in each arm. Estimated study duration is 6 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional asthma therapy.
Bilevel Positive Airway Pressure group(BiPAP). BiPAP settings at 15/5 cm H2O by face mask with background rate 10 to 15/min. Standard steroid dose plus hourly salbutamol and oxygen to keep SaO2 \> 92%.
Ipratropium
Nebulized q6h
Magnesium Sulfate
50mg/kg IV, 4 doses q6h
Aminophylline
6mg/kg IV (if no progress)
Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.
Non-invasive ventilation (CPAP).
Continuous Positive Airway Pressure group (CPAP). CPAP settings at 8 to 10 cm H2O. Standard steroid dose plus hourly salbutamol and oxygen to keep SaO2 \> 92%.
CPAP
The patient breathes against a constant pressure delivered by face mask.
Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.
Non-invasive ventilation (BiPAP)
Standard steroid dose, hourly salbutamol, oxygen as needed, nebulized ipratropium q 6 hrly, magnesium sulfate 50 mg/kg IV (4 doses q 6 hrly), loading dose of aminophylline 6 mg/kg IV if no progress.
BiPAP
The patient's breathing is assisted by cycling between high and low pressures at a pre-set rate.
Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BiPAP
The patient's breathing is assisted by cycling between high and low pressures at a pre-set rate.
CPAP
The patient breathes against a constant pressure delivered by face mask.
Ipratropium
Nebulized q6h
Magnesium Sulfate
50mg/kg IV, 4 doses q6h
Aminophylline
6mg/kg IV (if no progress)
Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical diagnosis of acute asthma exacerbation (respiratory rate greater than WHO's age-dependent criteria, a history of similar previous episodes and wheezing heard on auscultation by an experienced physician)
* PRAM score of 8 or more after 2 hours post-steroid administration
* Parents willing and able to sign consent
* Children over the age of 6 willing to provide assent
Exclusion Criteria
* Impending respiratory failure at presentation requiring direct PICU admission
* Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway, pneumothorax.
* Receiving maintenance dose of oral steroid at time of hospital admission
* History of serious unrelated illness such as congenital heart disease or bronchopulmonary dysplasia.
2 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michael Seear
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Seear
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Gowraiah V, Awasthi S, Kapoor R, Sahana D, Venkatesh P, Gangadhar B, Awasthi A, Verma A, Pai N, Seear M. Can we distinguish pneumonia from wheezy diseases in tachypnoeic children under low-resource conditions? A prospective observational study in four Indian hospitals. Arch Dis Child. 2014 Oct;99(10):899-906. doi: 10.1136/archdischild-2013-305740. Epub 2014 Jun 12.
Basnet S, Mander G, Andoh J, Klaska H, Verhulst S, Koirala J. Safety, efficacy, and tolerability of early initiation of noninvasive positive pressure ventilation in pediatric patients admitted with status asthmaticus: a pilot study. Pediatr Crit Care Med. 2012 Jul;13(4):393-8. doi: 10.1097/PCC.0b013e318238b07a.
Ducharme FM, Chalut D, Plotnick L, Savdie C, Kudirka D, Zhang X, Meng L, McGillivray D. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr. 2008 Apr;152(4):476-80, 480.e1. doi: 10.1016/j.jpeds.2007.08.034. Epub 2007 Oct 31.
Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13.
Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7.
British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. doi: 10.1136/thorax.57.3.192. No abstract available.
Nievas IF, Anand KJ. Severe acute asthma exacerbation in children: a stepwise approach for escalating therapy in a pediatric intensive care unit. J Pediatr Pharmacol Ther. 2013 Apr;18(2):88-104. doi: 10.5863/1551-6776-18.2.88.
Papiris SA, Manali ED, Kolilekas L, Triantafillidou C, Tsangaris I. Acute severe asthma: new approaches to assessment and treatment. Drugs. 2009;69(17):2363-91. doi: 10.2165/11319930-000000000-00000.
Green E, Jain P, Bernoth M. Noninvasive ventilation for acute exacerbations of asthma: A systematic review of the literature. Aust Crit Care. 2017 Nov;30(6):289-297. doi: 10.1016/j.aucc.2017.01.003. Epub 2017 Jan 27.
Soroksky A, Klinowski E, Ilgyev E, Mizrachi A, Miller A, Ben Yehuda TM, Shpirer I, Leonov Y. Noninvasive positive pressure ventilation in acute asthmatic attack. Eur Respir Rev. 2010 Mar;19(115):39-45. doi: 10.1183/09059180.00006109.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H17-02008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.