Asthma in Children Clinical Trial
Official title:
A Prospective Open Randomized Clinical Trial of Non-invasive Ventilation Versus Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma.
Acute asthma produces greatly increased work of breathing and increased oxygen requirement secondary to bronchial narrowing and airway obstruction by inflammatory secretions. There is growing evidence that non-invasive ventilation can reverse these processes more efficiently than conventional asthma therapy. Surprisingly, there have not yet been any large scale prospective controlled studies to investigate this hypothesis, (either in adults or children). Consequently, the aim of this study is to determine if the use of non-invasive positive airway pressure, for children admitted to hospital with an acute exacerbation of asthma, reduces their work of breathing, need for adjunctive medications, and shortens the length of hospital stay, compared to current standard therapy.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility |
Inclusion Criteria: - 2-18 years old - 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: - Clinical suspicion of bacterial pneumonia: focal crackles or bronchial breathing, and/or major chest x-ray findings. - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of British Columbia | Post Graduate Institute of Medical Education and Research, Chandigarh |
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. — View Citation
British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time to reach FEV1 >80% predicted in those children able to perform pulmonary function tests | Standard pulmonary function tests can usually be performed by children >6 years. | Patients will be followed for the duration of their hospital stay (an estimated average of 4 days). | |
Primary | Time to reach a PRAM score of =3 | PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing. | Patients will be followed for the duration of their hospital stay (an estimated average duration of 4 days) | |
Secondary | Time to room air | Time that oxygen is required | Patients will be followed for the duration of their hospital stay (an estimated average of 4 days). | |
Secondary | Total medication use per 12 hr period | Comparison of total medication use by children in each arm. | Patients will be followed for the duration of their hospital stay (an estimated average of 4 days). | |
Secondary | Numbers failing treatment and transferred to ICU | Number of patients in each group that fail treatment and require transfer to ICU | Patients will be followed for the duration of their hospital stay (an estimated average of 4 days). |
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