AsthmaNCT02347462
Bilevel Positive Airway Pressure (BiPAP) for the Treatment of Moderate to Severe Acute Asthma Exacerbations
A study testing Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics) in people with Asthma and Status Asthmaticus, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Asthma, Status Asthmaticus
- What is being tested?
- Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's and Women's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
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.
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.
Read the detailed 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.
- Conditions
- Asthma, Status Asthmaticus
- Being tested
- Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics), Standard care
- Keywords
- BiPAP
- Medical subject headings
- Asthma, Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics)Device
Also called 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.
Standard careOther
Standard care according to the hospital severe asthma protocol
| Study group | Role | What they receive |
|---|---|---|
| BiPAP plus standard care | Experimental | Bilevel Positive Airway Pressure (BiPAP) plus standard care according to the hospital's severe asthma protocol Receives: 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 Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at initiation, and 3-hourly thereafter until hospital discharge (an estimated average duration of 4 days)
Secondary outcomes (5)
Intubation and complication rates
Number of children in each arm requiring intubation and mechanical ventilation, and experiencing significant treatment-related side effects
Measured: 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
Number of children in each arm failing initial hospital discharge and requiring re-admission within 48 hours
Measured: Within 48 hours of initial hospital discharge
Inhaled bronchodilator utilization
Comparison of the median daily dose of inhaled salbutamol received by children in each arm,
Measured: 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
Comparison of the total number of hours of intravenous bronchodilator infusions received by children in each arm
Measured: 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
Duration of time from hospital admission to the patient meeting hospital discharge criteria
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: we were not able to work through the logistics of the study to support enrolment in ER
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seear, University of British Columbia
- Investigators
- Michael Seear, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347462
- Sponsor's protocol ID
- H14-02397
- Status last verified
- Sep 2017
- First submitted
- 14 Jan 2015
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24041942Papiris 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.
PubMed 19911854Soroksky 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.
PubMed 20956164Meduri 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.
PubMed 8797425Thill 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.
PubMed 15215002Basnet 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.
PubMed 22067982Ducharme 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.
PubMed 18346499
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02347462
- Acronym / sponsor ID
- H14-02397
- Conditions
- Asthma, Status Asthmaticus
- Keywords
- BiPAP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: we were not able to work through the logistics of the study to support enrolment in ER
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiPAP plus standard care | Experimental | Device: Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics), Other: Standard careBilevel Positive Airway Pressure (BiPAP) plus standard care according to the hospital's severe asthma protocol |
| Standard care alone | Active comparator | Other: Standard careStandard care according to the hospital's severe asthma protocol |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics)Also: Trilogy BiPAP, Philips RespironicsChildren 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. | Device | BiPAP plus standard care |
| Standard careStandard care according to the hospital severe asthma protocol | Other | BiPAP plus standard care, Standard care alone |
Primary outcome
Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of ≤ 3 (mild)
Time frame: Assessed at initiation, and 3-hourly thereafter until hospital discharge (an estimated average duration of 4 days)
PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing.
5 secondary outcomes
Intubation and complication rates
Time frame: 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
Time frame: Within 48 hours of initial hospital discharge
Inhaled bronchodilator utilization
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Background: PubMed 24041942Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13.
- Background: PubMed 19911854Papiris 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.
- Background: PubMed 20956164Soroksky 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.
- Background: PubMed 8797425Meduri 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.
- Background: PubMed 15215002Thill 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.
- Background: PubMed 22067982Basnet 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.
- Background: PubMed 18346499Ducharme 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Seear, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics) in people with Asthma and Status Asthmaticus, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of ≤ 3 (mild) (time frame: Assessed at initiation, and 3-hourly thereafter until hospital discharge (an estimated average duration of 4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02347462, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.