Airway Clearance ImpairmentNCT06000618
Effects of Intrapulmonary Percussive Ventilator on Respiratory Function
A study testing Intrapulmonary Percussive ventilator in people with Airway Clearance Impairment, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to prove the benefit of intrapulmonary percussive ventilator in healthy volunteers. The main questions are: How can intrapulmonary percussive improve lung function？ What is the subjective feeling through intrapulmonary percussive? Participants will be undergoing treatment of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Airway Clearance Impairment
- What is being tested?
- Intrapulmonary Percussive ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 May 2024
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No respiratory system, heart disease
- Well cooperate with the MateNeb
Who cannot join
- No respiratory illness such as influenza, pneumonia, asthma, bronchitis within the last month
- Couldn't finish three times pulmonary function test
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, 200040
Xin Jing, Dr, +8618917682679, lingzi_jx@163.com
Xing Qi Wang, Dr, +8618917683119, wangqixing1221@163.com
About this study
Official title: Effects of Intrapulmonary Percussive Ventilator on Respiratory Function: an Experiment in Healthy Volunteers
The goal of this clinical trial is to prove the benefit of intrapulmonary percussive ventilator in healthy volunteers. The main questions are:
- How can intrapulmonary percussive improve lung function？
- What is the subjective feeling through intrapulmonary percussive?
Participants will be undergoing treatment of intrapulmonary percussive. Then they will be assessed for lung function and EIT before and after intrapulmonary percussive.
- Conditions
- Airway Clearance Impairment
- Being tested
- Intrapulmonary Percussive ventilator
- Keywords
- Intrapulmonary percussive, Healthy volunteer, pulmonary function, Electrical Impedance Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapulmonary Percussive ventilatorDevice
Also called MateNeb
The volunteers will undergo three minutes low frequency and high frequency intrapulmonary percussive treatments.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group will undergo intrapulmonary percussive therapy Receives: Device: Intrapulmonary Percussive ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test
This test can assess the volunteer's lung ventilation and diffusion function.For example the max vital capacity (VCMAX),Forced vital capacity(FVC),Forced expiratory volume in one second(FEV1),functional residual capacity(FRC-SB),diffusion capacity of lung for carbon monoxide(DLCO) and so on.
Measured: through study completion, an average one hour
Electrical Impedance Tomography of Pulmonary(EIT)
EIT is a relatively advanced non-invasive monitoring technique for the lung function. This technology uses a strap attached to the chest to monitor electrical at 16 locations. The Ventilation in each area resistance of the lung is quantified according to the electrical resistance
Measured: through study completion, an average one hour
Secondary outcomes (1)
The safety and comfort
Whether the technique has adverse reactions. How do the volunteers feel? We used a scale of 1 to 4 to show how the volunteers felt. 1 is the worst feeling. The volunteers were no longer willing to undergo the treatment. 4 means the volunteers felt better and breathed easier after the treatment. Be willing to undergo endoairway shock therapy again.
Measured: The treatment was scored once after the participants completed both low and high frequency intrapulmonary percussive.Up to one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway Clearance ImpairmentStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Wang MD PhD, Shanghai 10th People's Hospital
- Investigators
- Sheng Wang, PHD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000618
- Sponsor's protocol ID
- STPH-ICU-006
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hassan A, Milross M, Lai W, Shetty D, Alison J, Huang S. Feasibility and safety of intrapulmonary percussive ventilation in spontaneously breathing, non-ventilated patients in critical care: A retrospective pilot study. J Intensive Care Soc. 2021 May;22(2):111-119. doi: 10.1177/1751143720909704. Epub 2020 Mar 12.
PubMed 34025750Nyland BA, Spilman SK, Halub ME, Lamb KD, Jackson JA, Oetting TW, Sahr SM. A Preventative Respiratory Protocol to Identify Trauma Subjects at Risk for Respiratory Compromise on a General In-Patient Ward. Respir Care. 2016 Dec;61(12):1580-1587. doi: 10.4187/respcare.04729. Epub 2016 Nov 8.
PubMed 27827332
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intrapulmonary Percussive Ventilator on Respiratory Function: an Experiment in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06000618
- Acronym / sponsor ID
- STPH-ICU-006
- Conditions
- Airway Clearance Impairment
- Keywords
- Intrapulmonary percussive, Healthy volunteer, pulmonary function, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- 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.
The goal of this clinical trial is to prove the benefit of intrapulmonary percussive ventilator in healthy volunteers. The main questions are:
- How can intrapulmonary percussive improve lung function？
- What is the subjective feeling through intrapulmonary percussive?
Participants will be undergoing treatment of intrapulmonary percussive. Then they will be assessed for lung function and EIT before and after intrapulmonary percussive.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Intrapulmonary Percussive ventilatorThe experimental group will undergo intrapulmonary percussive therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No respiratory system, heart disease
- Well cooperate with the MateNeb
Key exclusion criteria (2 listed)
- No respiratory illness such as influenza, pneumonia, asthma, bronchitis within the last month
- Couldn't finish three times pulmonary function test
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 ventilatorAlso: MateNebThe volunteers will undergo three minutes low frequency and high frequency intrapulmonary percussive treatments. | Device | experimental group |
Primary outcome
Pulmonary function test
Time frame: through study completion, an average one hour
This test can assess the volunteer's lung ventilation and diffusion function.For example the max vital capacity (VCMAX),Forced vital capacity(FVC),Forced expiratory volume in one second(FEV1),functional residual capacity(FRC-SB),diffusion capacity of lung for carbon monoxide(DLCO) and so on.
Electrical Impedance Tomography of Pulmonary(EIT)
Time frame: through study completion, an average one hour
EIT is a relatively advanced non-invasive monitoring technique for the lung function. This technology uses a strap attached to the chest to monitor electrical at 16 locations. The Ventilation in each area resistance of the lung is quantified according to the electrical resistance
1 secondary outcome
The safety and comfort
Time frame: The treatment was scored once after the participants completed both low and high frequency intrapulmonary percussive.Up to one week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 34025750Hassan A, Milross M, Lai W, Shetty D, Alison J, Huang S. Feasibility and safety of intrapulmonary percussive ventilation in spontaneously breathing, non-ventilated patients in critical care: A retrospective pilot study. J Intensive Care Soc. 2021 May;22(2):111-119. doi: 10.1177/1751143720909704. Epub 2020 Mar 12.
- Results publication: PubMed 27827332Nyland BA, Spilman SK, Halub ME, Lamb KD, Jackson JA, Oetting TW, Sahr SM. A Preventative Respiratory Protocol to Identify Trauma Subjects at Risk for Respiratory Compromise on a General In-Patient Ward. Respir Care. 2016 Dec;61(12):1580-1587. doi: 10.4187/respcare.04729. Epub 2016 Nov 8.
- 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.
Sheng Wang, PHD principal investigator
Shanghai 10th People's Hospital
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 ventilator in people with Airway Clearance Impairment, run by Shanghai 10th People's Hospital at 1 site in China.
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 2 inclusion and 2 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 21 Aug 2023. 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 China. 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 Xin Jing, Dr (+86-18917682679, lingzi_jx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (time frame: through study completion, an average one hour). 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?
On the ClinicalTrials.gov record for NCT06000618, which also lists 2 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 Aug 2023.