Bilevel Positive Airway Pressure (BiPAP) for the Treatment of Moderate to Severe Acute Asthma Exacerbations

Asthma Clinical Trial

Official title:

A Prospective Open Randomized Clinical Trial Comparing Bilevel Positive Airway Pressure (BiPAP) Therapy Against Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma Unresponsive to Inhaled Bronchodilators.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02347462
• Other study ID #: H14-02397
• Status: Withdrawn
• Phase: N/A
• First received: January 14, 2015
• Last updated: September 19, 2017
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bilevel Positive Airway Pressure (BiPAP) is increasingly being reported as an effective and safe method of respiratory support for children with severe asthma exacerbations unresponsive to standard therapies and with impending respiratory failure. Much of the evidence base supporting its use comes from retrospective observational studies, and there is currently a lack of data from randomized controlled trials to inform this practice.

The investigators hypothesize that the use of BiPAP in children with moderate to severe asthma exacerbations could reduce the length of hospital stay, need for invasive ventilation, and use of intravenous bronchodilators. The investigators aim to test this hypothesis by randomizing children attending the Emergency Department with a moderate to severe clinical severity score refractory to inhaled bronchodilators to receive either BiPAP in addition to standard asthma care, or standard care alone.

Description:

Children aged 2 - 18 years presenting to the Emergency Department (ED) with a moderate or severe asthma exacerbation (Pediatric Respiratory Assessment Measure (PRAM) of > 3) who fail to improve clinically with standard ED management with inhaled salbutamol and ipratropium will be randomized to receive either standard asthma management according to our local severe asthma guideline or management with BiPAP in addition to standard care. Both groups will receive a comparable dose of systemic steroid and hourly salbutamol inhalers with subsequent weaning according to PRAM score. Patients randomized to receive BiPAP will be admitted to the Pediatric Intensive Care Unit (PICU) and those randomized to the control group will be admitted to the medical ward. Both groups will be monitored with 3-hourly PRAM scoring through the duration of their admission.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• 2-18 years old

• Admitted to BC Children's Hospital with a clinical diagnosis of an acute asthma exacerbation

• PRAM score of >3 following initial treatment with three rounds of inhaled salbutamol and ipratropium bromide, and one dose of systemic steroid

• Parents willing and able to sign consent

• Children over the age of 6 willing to provide assent

Exclusion Criteria:

• Clinical suspicion of co-existing bacterial pneumonia: focal crackles or bronchial breathing, and/or major chest x-ray findings

• Impending respiratory failure at presentation requiring direct PICU admission

• Receiving maintenance dose of oral steroid at time of hospital admission

• Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, or inability to protect airway

• Current tracheostomy, home ventilation (IPPV or NIPPV) or home oxygen requirement

• History of congenital heart disease or chronic respiratory disease (including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension)

• Craniofacial abnormality precluding the use of a tight fitting facial mask

Related Conditions & MeSH terms

• Asthma
• Status Asthmaticus

Intervention

Device:
• Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics)
Children in the intervention group will receive BiPAP (Trilogy, Philips Respironics; spontaneous trigger mode) via a nasal or full face mask. End expiratory positive airway pressure (EPAP) will be set at 5cm H20. Inspiratory positive airway pressure (IPAP) will be titrated to achieve a tidal volume of 6 - 9 ml/kg. These settings will remain unchanged throughout the study period.

Other:
• Standard care
Standard care according to the hospital severe asthma protocol

Locations

Country	Name	City	State
Canada	Children's and Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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

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

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

Meduri GU, Cook TR, Turner RE, Cohen M, Leeper KV. Noninvasive positive pressure ventilation in status asthmaticus. Chest. 1996 Sep;110(3):767-74. — 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

Thill PJ, McGuire JK, Baden HP, Green TP, Checchia PA. Noninvasive positive-pressure ventilation in children with lower airway obstruction. Pediatr Crit Care Med. 2004 Jul;5(4):337-42. Erratum in: Pediatr Crit Care Med. 2004 Nov;5(6):590. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of = 3 (mild)	PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing.	Assessed at initiation, and 3-hourly thereafter until hospital discharge (an estimated average duration of 4 days)
Secondary	Intubation and complication rates	Number of children in each arm requiring intubation and mechanical ventilation, and experiencing significant treatment-related side effects	Patients will be followed for the duration of their hospital stay (an estimated average of 4 days) with data collection relative to this outcome on a daily basis
Secondary	Hospital re-admission	Number of children in each arm failing initial hospital discharge and requiring re-admission within 48 hours	Within 48 hours of initial hospital discharge
Secondary	Inhaled bronchodilator utilization	Comparison of the median daily dose of inhaled salbutamol received by children in each arm,	Patients will be followed for the duration of their hospital stay (an estimated average of 4 days) with data collection relative to this outcome on a daily basis
Secondary	Intravenous bronchodilator utilization	Comparison of the total number of hours of intravenous bronchodilator infusions received by children in each arm	Patients will be followed for the duration of their hospital stay (an estimated average of 4 days) with data collection relative to this outcome on a daily basis
Secondary	Length of hospital stay	Duration of time from hospital admission to the patient meeting hospital discharge criteria	Length of stay will be calculated at the time of each child's hospital discharge (estimated 4 days after hospital admission and recruitment to study)