NCT06000618

Brief 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 intrapulmonary percussive. Then they will be assessed for lung function and EIT before and after intrapulmonary percussive.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

July 20, 2023

Last Update Submit

August 16, 2023

Conditions

Airway Clearance Impairment

Keywords

Intrapulmonary percussiveHealthy volunteerpulmonary functionElectrical Impedance Tomography

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    through study completion, an average one hour

Secondary Outcomes (1)

  • The safety and comfort

    The treatment was scored once after the participants completed both low and high frequency intrapulmonary percussive.Up to one week.

Study Arms (1)

experimental group

EXPERIMENTAL

The experimental group will undergo intrapulmonary percussive therapy

Device: Intrapulmonary Percussive ventilator

Interventions

Intrapulmonary Percussive ventilatorDEVICE

The volunteers will undergo three minutes low frequency and high frequency intrapulmonary percussive treatments.

Also known as: MateNeb
experimental group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No respiratory system, heart disease
  • Well cooperate with the MateNeb

You may not qualify if:

  • No respiratory illness such as influenza, pneumonia, asthma, bronchitis within the last month
  • Couldn't finish three times pulmonary function test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, 200040, China

Location

Related Publications (2)

  • 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.

    PMID: 34025750BACKGROUND

  • Nyland 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.

    PMID: 27827332RESULT

Study Officials

  • Sheng Wang, PHD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Jing, Dr

CONTACT

+86-18917682679lingzi_jx@163.com

Xing Qi Wang, Dr

CONTACT

+86-18917683119wangqixing1221@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 21, 2023

Study Start

September 1, 2023

Primary Completion

December 30, 2023

Study Completion

May 31, 2024

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)