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

NCT02347462 | Withdrawn

• 1 other identifier: H14-02397
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Status Asthmaticus

Keywords

BiPAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intubation and complication rates

  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

• Hospital re-admission

  Within 48 hours of initial hospital discharge

• Inhaled bronchodilator utilization

  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

• Intravenous bronchodilator utilization

  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

• Length of hospital stay

  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)

Study Arms (2)

BiPAP plus standard care

EXPERIMENTAL

Bilevel Positive Airway Pressure (BiPAP) plus standard care according to the hospital's severe asthma protocol

Device: Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics); Other: Standard care

Standard care alone

ACTIVE COMPARATOR

Standard care according to the hospital's severe asthma protocol

Other: Standard care

Interventions

Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics) DEVICE

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.

Also known as: Trilogy BiPAP, Philips Respironics

BiPAP plus standard care

Standard care OTHER

Standard care according to the hospital severe asthma protocol

BiPAP plus standard care; Standard care alone

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Children's and Women's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (7)

• 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.

  PMID: 24041942 BACKGROUND

• 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.

  PMID: 19911854 BACKGROUND

• 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.

  PMID: 20956164 BACKGROUND

• Meduri GU, Cook TR, Turner RE, Cohen M, Leeper KV. Noninvasive positive pressure ventilation in status asthmaticus. Chest. 1996 Sep;110(3):767-74. doi: 10.1378/chest.110.3.767.

  PMID: 8797425 BACKGROUND

• 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. doi: 10.1097/01.pcc.0000128670.36435.83.

  PMID: 15215002 BACKGROUND

• 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.

  PMID: 22067982 BACKGROUND

• 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.

  PMID: 18346499 BACKGROUND

MeSH Terms

Conditions

Asthma; Status Asthmaticus

Interventions

Continuous Positive Airway Pressure; Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Seear, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 27, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

CA (1)