Status AsthmaticusPhase 1NCT01188473
Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus
A Phase 1 study of Status Asthmaticus, run by Southern Illinois University at 1 site in United States.
Trial summary
Status asthmaticus is recognized as a common cause of morbidity in children in the United States. In recent years, hospitalization rates have reached an all time high. This study will evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive Pressure Ventilation (NPPV)to regular care in… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Status Asthmaticus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2010
- Phase
- Phase 1
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children, 1- 18 years of age, with a known history of asthma admitted to the PICU at St John's Children's Hospital with status asthmaticus
- clinical asthma score (CAS) between 3 - 8 after receiving one dose of systemic steroid, 1 hour of continuous albuterol (SABA), and 3 doses of ipratropium bromide
- written informed consent from the patient's parent or legal guardian
Who cannot join
- no previous history of asthma,
- absence of airway protective reflexes,
- absence of respiratory drive,
- excessive oral secretions,
- need for emergent intubation as determined by the attending physician,
- facial or airway anomaly or injury precluding the use of tight fitting mask
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9676
About this study
Official title: Safety and Efficacy of Early Initiation of Noninvasive Positive Pressure Ventilation in Pediatric Patients Admitted With Status Asthmaticus
Status asthmaticus is recognized as a common cause of morbidity in children in the United States. In recent years, hospitalization rates have reached an all time high. This study will evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive Pressure Ventilation (NPPV)to regular care in children with moderate to moderately severe status asthmaticus.
Read the detailed description
Status asthmaticus is defined as severe asthma that fails to respond to inhaled short acting β agonists (SABA), oral or intravenous steroids, and oxygen, leading to hospital admission for further management (1). In 2004, asthma exacerbations led to 3% (198,000) of all hospitalizations and 2.5 deaths per 1 million populations in the 0-17 year age group (2).
This prospective, unblinded, randomized controlled, pilot clinical trial will compare NPPV plus standard of care versus standard of care alone in children admitted for status asthmaticus. NPPV refers to the delivery of pressurized gas through an external interface such as a nasal or oronasal mask, connected to a pressure targeted ventilator. In other words, it provides ventilator support without the use of an endotracheal tube.
This study will investigate the safety, tolerability and efficacy of early initiation of non-invasive NPPV in pediatric patients admitted with status asthmaticus.
- Conditions
- Status Asthmaticus
- Being tested
- NPPV plus standard of care
- Keywords
- Status Asthmaticus, Noninvasive Positive Pressure Ventilation, Asthma in Children
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPPV plus standard of careOther
Also called Comfortgel Masks, Respironics, Vision Bipap, Respironics
Patients in the NPPV group were fitted with a nasal mask with gel seals (Comfortgel Masks, Respironics) and placed on the BiPAP Machine (Vision Bipap, Respironics). To optimize patient cooperation, the mask was initially applied manually to the patient's face. After a short adaptation period, it was firmly applied on the face by head straps to minimize air leak without causing skin injury. Pressures were initially set low for comfort and acceptance while being placed on the machine. The inspiratory positive airway pressure (IPAP) was gradually increased to 8 cm H2O in order to achieve a tidal volume of 6-9 ml/kg and the end expiratory positive airway pressure (EPAP) to 5 cm H 2O. These settings remained unchanged throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| NPPV plus standard of care | Experimental | NPPV initiated early and for a prolonged period of time in addition to standard of care in the management of children admitted to the hospital with status asthmaticus Receives: Other: NPPV plus standard of care |
| Control: standard of care alone | No intervention | standard of care in the management of children admitted to the hospital with status asthmaticus |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical asthma score (CAS)
clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I\&E ratio, retractions
Measured: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Secondary outcomes (6)
heart rate
determined by heart monitor
Measured: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
being able to wear the mask
Patient is able to keep the mask on for 24 hours.
Measured: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
transcutaneous oxygen saturation
Measured: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
mental status
observation of activity level, agitation, etc.
Measured: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
supplemental oxygen
Measured: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
NPPV related side effects
NPPV related side effects could be minor including nasal bridge pain and skin irritation, gastric insufflations, sinus and ear pain, and dry eyes
Measured: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Pilot early noninvasive ventilation on all children who met the criteria was effective.
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sangita Basnet, MD, Principal investigator, Southern Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188473
- Sponsor's protocol ID
- BAS-SIU-10-005
- Status last verified
- Dec 2014
- First submitted
- 23 Aug 2010
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Early Initiation of Noninvasive Positive Pressure Ventilation in Pediatric Patients Admitted With Status Asthmaticus
- ClinicalTrials.gov ID
- NCT01188473
- Acronym / sponsor ID
- BAS-SIU-10-005
- Conditions
- Status Asthmaticus
- Keywords
- Status Asthmaticus, Noninvasive Positive Pressure Ventilation, Asthma in Children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pilot early noninvasive ventilation on all children who met the criteria was effective.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Aug 2010 (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.
Status asthmaticus is recognized as a common cause of morbidity in children in the United States. In recent years, hospitalization rates have reached an all time high. This study will evaluate the safety, tolerability and clinical benefit of adding Noninvasive Positive Pressure Ventilation (NPPV)to regular care in children with moderate to moderately severe status asthmaticus.
Detailed description
Status asthmaticus is defined as severe asthma that fails to respond to inhaled short acting β agonists (SABA), oral or intravenous steroids, and oxygen, leading to hospital admission for further management (1). In 2004, asthma exacerbations led to 3% (198,000) of all hospitalizations and 2.5 deaths per 1 million populations in the 0-17 year age group (2).
This prospective, unblinded, randomized controlled, pilot clinical trial will compare NPPV plus standard of care versus standard of care alone in children admitted for status asthmaticus. NPPV refers to the delivery of pressurized gas through an external interface such as a nasal or oronasal mask, connected to a pressure targeted ventilator. In other words, it provides ventilator support without the use of an endotracheal tube.
This study will investigate the safety, tolerability and efficacy of early initiation of non-invasive NPPV in pediatric patients admitted with status asthmaticus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPPV plus standard of care | Experimental | Other: NPPV plus standard of careNPPV initiated early and for a prolonged period of time in addition to standard of care in the management of children admitted to the hospital with status asthmaticus |
| Control: standard of care alone | No intervention | –standard of care in the management of children admitted to the hospital with status asthmaticus |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children, 1- 18 years of age, with a known history of asthma admitted to the PICU at St John's Children's Hospital with status asthmaticus
- clinical asthma score (CAS) between 3 - 8 after receiving one dose of systemic steroid, 1 hour of continuous albuterol (SABA), and 3 doses of ipratropium bromide
- written informed consent from the patient's parent or legal guardian
Key exclusion criteria (6 listed)
- no previous history of asthma,
- absence of airway protective reflexes,
- absence of respiratory drive,
- excessive oral secretions,
- need for emergent intubation as determined by the attending physician,
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 |
|---|---|---|
| NPPV plus standard of careAlso: Comfortgel Masks, Respironics, Vision Bipap, RespironicsPatients in the NPPV group were fitted with a nasal mask with gel seals (Comfortgel Masks, Respironics) and placed on the BiPAP Machine (Vision Bipap, Respironics). To optimize patient cooperation, the mask was initially applied manually to the patient's face. After a short adaptation period, it was firmly applied on the face by head straps to minimize air leak without causing skin injury. Pressures were initially set low for comfort and acceptance while being placed on the machine. The inspiratory positive airway pressure (IPAP) was gradually increased to 8 cm H2O in order to achieve a tidal volume of 6-9 ml/kg and the end expiratory positive airway pressure (EPAP) to 5 cm H 2O. These settings remained unchanged throughout the study period. | Other | NPPV plus standard of care |
Primary outcome
clinical asthma score (CAS)
Time frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
clinical evaluations such as wheezing, degree of air exchange, respiratory rate, I\&E ratio, retractions
6 secondary outcomes
heart rate
Time frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
being able to wear the mask
Time frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
transcutaneous oxygen saturation
Time frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
mental status
Time frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
supplemental oxygen
Time frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
NPPV related side effects
Time frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation
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 19 Dec 2014.
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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.
Sangita Basnet, MD principal investigator
Southern Illinois University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Status Asthmaticus, run by Southern Illinois University 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 3 inclusion and 6 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 19 Dec 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 score (CAS) (time frame: initiation, 2 hours, 4-8 hours, 12-16 hours and 24 hours after initiation). 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 19 Dec 2014.