AsthmaRCT BiPAPNCT01497691
Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
A study testing NIPPV (PALMtop PTV), Volumetric CO2 (NM3) and USCOM in people with Asthma, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- NIPPV (PALMtop PTV), Volumetric CO2 (NM3) and USCOM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 19 Nov 2013
- 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
- For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the Vanderbilt problem list
- For children ages 2-3 years, four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens
- Acute asthma exacerbation
- Pediatric Asthma Score (PAS) ≥ 8
- Parents willing and able to sign consent
- Children over the age of 6 willing to provide assent
Who cannot join
- History of congenital heart disease, chronic respiratory disease including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension or any chronic lung disease other than asthma
- History of sickle cell disease
- Recently diagnosed pneumonia
- Current tracheostomy, on home ventilator or home oxygen requirement
- Recent diabetic ketoacidosis
- Requiring immediate intubation
Show all 9Show fewer
- Weight less than 5 kilograms
- Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway
- A history of prematurity of ≤ 30 weeks gestation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
About this study
Official title: A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in children with respiratory insufficiency, emergency department and ICU stays may be shortened, and the need for more invasive and dangerous airway procedures may be decreased. This would result in a change in the standard of care for asthma treatment in emergency departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction with current standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress, and overall improved secondary outcomes.
- Conditions
- Asthma
- Being tested
- NIPPV (PALMtop PTV), Volumetric CO2 (NM3), USCOM
- Keywords
- Asthma, Pediatrics, BiPAP, Noninvasive Positive Pressure Ventilation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPPV (PALMtop PTV)Device
PALMtop PTV Models 8/10 aka CareFusion EnVe The primary study device is the PALMtop PTV. It is the NIPPV/BiPAP device used in this study. It is FDA approved for use in children who weigh 5 kilograms or greater (#K070594).
Volumetric CO2 (NM3)Device
The NM3 is FDA approved (#K091459) for spirometric and carbon dioxide monitoring as well as continuous, non-invasive monitoring of arterial oxygen saturations and pulse rates in neonatal and pediatric patients in the emergency department.
USCOMDevice
The USCOM a non-invasive ultrasonic device that is FDA approved for monitor beat-to-beat cardiac hemodynamics in adult and pediatric patients (#K043139). It will be used in an attempt to better understand the underlying physiology of NIPPV use.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. Receives: Device: USCOM |
| Sham NIPPV | Sham comparator | This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. The pressure settings will be fixed at a positive end-expiratory pressure (PEEP) of 5-8 cm H2O. Receives: Device: NIPPV (PALMtop PTV); Device: Volumetric CO2 (NM3); Device: USCOM |
| BiPAP | Active comparator | This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. Settings will be adjusted based on the age and clinical presentation of the child. Receives: Device: NIPPV (PALMtop PTV); Device: Volumetric CO2 (NM3); Device: USCOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Asthma Score
The primary outcome indicator will be a decrease in PAS to ≤ to 7 to occur 3 hours faster in the NIPPV/BiPAP group as compared to the control group (median expected time to PAS 7 ≤ in BiPAP group is 5 hours; median expected time to PAS ≤ 7 in control group is 8 hours; hazard ratio is 1.6). A total sample size of 366 (122 in each group) is required for 80% power and a significance level of 0.05 (2 tailed test). With an estimated 20% drop out rate will anticipate 147 subjects enrolled per arm for a total of 441 subjects enrolled.
Measured: Every 30 minutes while the subject is enrolled
Secondary outcomes (5)
Volumetric end tidal CO2 trend
Measurement of volumetric end tidal CO2 trend with the NICO2® Respiratory volumetric capnography CO2 monitors
Measured: Continuous while the subject is enrolled
Respiratory parameters
Analysis of flow loops captured by the NIPPV device, the delta pediatric asthma scores at each time point and changes in individual pulmonary parameters (respiratory rate, oxygen requirement, oxygen saturation).
Measured: Continuous while the subject is enrolled
Cardiac output
Changes in cardiac parameters as measured by the USCOM
Measured: Continuous while the subject is enrolled
Intubation and complication rates
Documentation of intubation rate and possible complications including but not limited to hypotension, vomiting, agitation, skin irritation, pneumothorax, barotrauma effects and death.
Measured: Continuous observation
Length of hospital stay
Decrease length of hospital stay if placed on NIPPV. This will include looking at the disposition of the subject from the pediatric emergency department.
Measured: Retrospectively upon completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startJan 2013 (estimated)
- Primary completion19 Nov 2013
- Study completion19 Nov 2013
Why it stopped: unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abby M Williams, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497691
- Sponsor's protocol ID
- 111491
- Acronym
- RCT BiPAP
- Status last verified
- Aug 2017
- First submitted
- 16 Dec 2011
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
- ClinicalTrials.gov ID
- NCT01497691
- Acronym / sponsor ID
- RCT BiPAP / 111491
- Conditions
- Asthma
- Keywords
- Asthma, Pediatrics, BiPAP, Noninvasive Positive Pressure Ventilation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2013 (estimated)
- Primary completion
- 19 Nov 2013 (actual)
- Study completion
- 19 Nov 2013 (actual)
- First posted
- 22 Dec 2011 (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.
Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in children with respiratory insufficiency, emergency department and ICU stays may be shortened, and the need for more invasive and dangerous airway procedures may be decreased. This would result in a change in the standard of care for asthma treatment in emergency departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction with current standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress, and overall improved secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Device: USCOMThis group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. |
| Sham NIPPV | Sham comparator | Device: NIPPV (PALMtop PTV), Device: Volumetric CO2 (NM3), Device: USCOMThis group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. The pressure settings will be fixed at a positive end-expiratory pressure (PEEP) of 5-8 cm H2O. |
| BiPAP | Active comparator | Device: NIPPV (PALMtop PTV), Device: Volumetric CO2 (NM3), Device: USCOMThis group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. Settings will be adjusted based on the age and clinical presentation of the child. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 2-18 years old
- For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the Vanderbilt problem list
- For children ages 2-3 years, four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens
- Acute asthma exacerbation
- Pediatric Asthma Score (PAS) ≥ 8
Key exclusion criteria (9 listed)
- History of congenital heart disease, chronic respiratory disease including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension or any chronic lung disease other than asthma
- History of sickle cell disease
- Recently diagnosed pneumonia
- Current tracheostomy, on home ventilator or home oxygen requirement
- Recent diabetic ketoacidosis
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 |
|---|---|---|
| NIPPV (PALMtop PTV)PALMtop PTV Models 8/10 aka CareFusion EnVe The primary study device is the PALMtop PTV. It is the NIPPV/BiPAP device used in this study. It is FDA approved for use in children who weigh 5 kilograms or greater (#K070594). | Device | BiPAP, Sham NIPPV |
| Volumetric CO2 (NM3)The NM3 is FDA approved (#K091459) for spirometric and carbon dioxide monitoring as well as continuous, non-invasive monitoring of arterial oxygen saturations and pulse rates in neonatal and pediatric patients in the emergency department. | Device | BiPAP, Sham NIPPV |
| USCOMThe USCOM a non-invasive ultrasonic device that is FDA approved for monitor beat-to-beat cardiac hemodynamics in adult and pediatric patients (#K043139). It will be used in an attempt to better understand the underlying physiology of NIPPV use. | Device | BiPAP, Control, Sham NIPPV |
Primary outcome
Change in Pediatric Asthma Score
Time frame: Every 30 minutes while the subject is enrolled
The primary outcome indicator will be a decrease in PAS to ≤ to 7 to occur 3 hours faster in the NIPPV/BiPAP group as compared to the control group (median expected time to PAS 7 ≤ in BiPAP group is 5 hours; median expected time to PAS ≤ 7 in control group is 8 hours; hazard ratio is 1.6). A total sample size of 366 (122 in each group) is required for 80% power and a significance level of 0.05 (2 tailed test). With an estimated 20% drop out rate will anticipate 147 subjects enrolled per arm for a total of 441 subjects enrolled.
5 secondary outcomes
Volumetric end tidal CO2 trend
Time frame: Continuous while the subject is enrolled
Respiratory parameters
Time frame: Continuous while the subject is enrolled
Cardiac output
Time frame: Continuous while the subject is enrolled
Intubation and complication rates
Time frame: Continuous observation
Length of hospital stay
Time frame: Retrospectively upon completion of 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 24 Aug 2017.
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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.
Abby M Williams, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIPPV (PALMtop PTV), Volumetric CO2 (NM3) and USCOM in people with Asthma, run by Vanderbilt University Medical Center at 1 site in United States.
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 7 inclusion and 9 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 24 Aug 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 United States. 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. Some participants in this study may receive a placebo. 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?
Change in Pediatric Asthma Score (time frame: Every 30 minutes while the subject is enrolled). 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 24 Aug 2017.