BronchiolitisNCT03037801
Intrapulmonary Percussive Ventilation for Children With Bronchiolitis on Non-Invasive Ventilation Support
A study testing Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho) in people with Bronchiolitis, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to Jul 2018
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Bronchiolitis
- PICU patients
- Non Invasive Pressure Support Ventilation
- Age < 24 months
Who cannot join
- Age > 24 months
- Invasive Ventilation
- No parental consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka Medical Center
Beersheba
Yuval Cavari, MD, 972504562280, cavari@bgu.ac.il
About this study
Official title: Prospective Randomized Controlled Study of the Use of Intrapulmonary Percussive Ventilation (IPV) for Children With Bronchiolitis Admitted to the Pediatric Intensive Care Unit (PICU) and Are on Non-Invasive Ventilation Support
Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation. The patient population will be divided into two groups, one group will receive conventional treatment and the other group will receive conventional treatment and three times a day of physiotherapy using Intrapulmonary Percussive Ventilation.
- Conditions
- Bronchiolitis
- Being tested
- Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)Device
IPV physiotherapy 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intrapulmonary Percussive Ventilation | Experimental | 15 minutes of IPV physiotherapy Receives: Device: Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of PICU Stay
Measured: 10 days
Need for Invasive Ventilation Support
Measured: 10 days
Secondary outcomes (2)
S/F ratio
Pulse oximetry saturation/fraction of inspired oxygen
Measured: Baseline, 15, 30 and 150 minutes after intervention
Prevention of lung atelectasis
Per chest x-ray
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completionMay 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuval Cavari, MD, Principal investigator, Soroka UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037801
- Sponsor's protocol ID
- SOR-0074-16 CTIL
- Status last verified
- Aug 2016
- First submitted
- 29 Jan 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study of the Use of Intrapulmonary Percussive Ventilation (IPV) for Children With Bronchiolitis Admitted to the Pediatric Intensive Care Unit (PICU) and Are on Non-Invasive Ventilation Support
- ClinicalTrials.gov ID
- NCT03037801
- Acronym / sponsor ID
- SOR-0074-16 CTIL
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 31 Jan 2017 (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.
Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation. The patient population will be divided into two groups, one group will receive conventional treatment and the other group will receive conventional treatment and three times a day of physiotherapy using Intrapulmonary Percussive Ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intrapulmonary Percussive Ventilation | Experimental | Device: Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)15 minutes of IPV physiotherapy |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Bronchiolitis
- PICU patients
- Non Invasive Pressure Support Ventilation
- Age < 24 months
Key exclusion criteria (3 listed)
- Age > 24 months
- Invasive Ventilation
- No parental consent
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 |
|---|---|---|
| Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)IPV physiotherapy 3 times a day | Device | Intrapulmonary Percussive Ventilation |
Primary outcome
Length of PICU Stay
Time frame: 10 days
Need for Invasive Ventilation Support
Time frame: 10 days
2 secondary outcomes
S/F ratio
Time frame: Baseline, 15, 30 and 150 minutes after intervention
Prevention of lung atelectasis
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Yuval Cavari, MD principal investigator
Soroka UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho) in people with Bronchiolitis, run by Soroka University Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Jun 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuval Cavari, MD (972-504562280, cavari@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of PICU Stay (time frame: 10 days). The study lists 2 primary outcomes in all. 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 2 Jun 2017.