Status AsthmaticusNCT02539420
A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus
A study testing BiPAP treatment in people with Status Asthmaticus, run by Northwell Health.
Trial summary
Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in… Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Status Asthmaticus
- What is being tested?
- BiPAP treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2016
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary diagnosis of asthma exacerbation
- Admitted to Cohen Children's Medical Center (CCMC) PICU
- CCMC respiratory severity score of 6 or higher at the time of enrollment
- Prior history of asthma or reactive airway disease
Who cannot join
- No prior history of asthma or reactive airway disease
- Facial or airway anomalies precluding BiPAP mask use
- Tracheostomy
- Lack of airway protective reflexes
- Neurologic or musculoskeletal abnormalities affecting respiration
- Underlying cardiovascular problems that may be negatively affected by positive pressure ventilation
- Intracranial problems (such as in the setting of head injury) that may be negatively affected by positive pressure ventilation
- Respiratory compromise for which emergent endotracheal intubation or non-invasive positive pressure ventilation is warranted as determined by the on-service attending physician
About this study
Official title: A Prospective, Randomized Trial of Early Versus Delayed BiPAP Administration or Non-positive Pressure Therapy in the Management of Pediatric Status Asthmaticus
Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. In this study, which is among the first randomized studies of BiPAP use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.
- Conditions
- Status Asthmaticus
- Being tested
- BiPAP treatment
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAP treatmentDevice
Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients assigned to the "control" group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation. |
| Late BiPAP treatment | Experimental | Patients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization. Receives: Device: BiPAP treatment |
| Early BiPAP treatment | Experimental | Patients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization. Receives: Device: BiPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Asthma Scores
Both PRAM and CCMC clinical asthma scores
Measured: 3 hours after enrollment
Secondary outcomes (6)
Dyspnea Scores
Modified Borg Scale and Wong Baker Faces Scale
Measured: 0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
BiPAP Tolerance
Tolerability of BiPAP will be determined by patients keeping the mask on and agreeing to remain on the machine for the intended treatment period.
Measured: Hospitalization
Length of stay in intensive care unit (ICU)
Measured: ICU stay -- Expected to be approximately 3 days on average
Length of stay in hospital
Measured: Hospital length of stay -- Expected to be approximately 5 days on average
Side effects or adverse events
Measured: Hospitalization
Clinical Asthma Scores
Measured: 0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startApr 2016
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status AsthmaticusStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Feinstein Institute for Medical Research
- Responsible party
- Principal investigator, Sandeep Gangadharan, Northwell Health
- Investigators
- Sandeep Gangadharan, MD, Principal investigator, Cohen Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539420
- Sponsor's protocol ID
- 14-245
- Status last verified
- Apr 2016
- First submitted
- 26 Aug 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial of Early Versus Delayed BiPAP Administration or Non-positive Pressure Therapy in the Management of Pediatric Status Asthmaticus
- ClinicalTrials.gov ID
- NCT02539420
- Acronym / sponsor ID
- 14-245
- Conditions
- Status Asthmaticus
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Feinstein Institute for Medical Research
- Study start
- Apr 2016
- Primary completion
- Apr 2016 (estimated)
- First posted
- 3 Sep 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.
Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. In this study, which is among the first randomized studies of BiPAP use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients assigned to the "control" group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation. |
| Late BiPAP treatment | Experimental | Device: BiPAP treatmentPatients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization. |
| Early BiPAP treatment | Experimental | Device: BiPAP treatmentPatients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primary diagnosis of asthma exacerbation
- Admitted to Cohen Children's Medical Center (CCMC) PICU
- CCMC respiratory severity score of 6 or higher at the time of enrollment
- Prior history of asthma or reactive airway disease
Key exclusion criteria (8 listed)
- No prior history of asthma or reactive airway disease
- Facial or airway anomalies precluding BiPAP mask use
- Tracheostomy
- Lack of airway protective reflexes
- Neurologic or musculoskeletal abnormalities affecting respiration
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 |
|---|---|---|
| BiPAP treatmentPatients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus | Device | Early BiPAP treatment, Late BiPAP treatment |
Primary outcome
Clinical Asthma Scores
Time frame: 3 hours after enrollment
Both PRAM and CCMC clinical asthma scores
6 secondary outcomes
Dyspnea Scores
Time frame: 0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
BiPAP Tolerance
Time frame: Hospitalization
Length of stay in intensive care unit (ICU)
Time frame: ICU stay -- Expected to be approximately 3 days on average
Length of stay in hospital
Time frame: Hospital length of stay -- Expected to be approximately 5 days on average
Side effects or adverse events
Time frame: Hospitalization
Clinical Asthma Scores
Time frame: 0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
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 27 Apr 2016.
Related trials for Status Asthmaticus
Not yet recruiting
Efficacy of High-Dose Continuous Intravenous Magnesium Sulfate Infusion vs Standard Intravenous Magnesium Sulfate Therapy in Status Asthmaticus in the ED
Asthma Exacerbation, Emergency Department
RecruitingPhase 2
Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
Asthma (Diagnosis)
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.
Sandeep Gangadharan, MD principal investigator
Cohen Children's Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP treatment in people with Status Asthmaticus, run by Northwell Health.
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 4 inclusion and 8 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 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical Asthma Scores (time frame: 3 hours after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2016.