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Effects of Intrapulmonary Percussive Ventilator on Respiratory Function

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06000618
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
9
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intrapulmonary Percussive ventilator
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Intrapulmonary Percussive Ventilator on Respiratory Function: an Experiment in Healthy Volunteers
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

The experimental group will undergo intrapulmonary percussive therapy

Device: Intrapulmonary Percussive ventilator
The volunteers will undergo three minutes low frequency and high frequency intrapulmonary percussive treatments.
Other Names:
  • MateNeb

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pulmonary function test [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.

    2. Electrical Impedance Tomography of Pulmonary(EIT) [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

    Secondary Outcome Measures

    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.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • No respiratory system, heart disease

    • Well cooperate with the MateNeb

    Exclusion Criteria:

    • No respiratory illness such as influenza, pneumonia, asthma, bronchitis within the last month

    • Couldn't finish three times pulmonary function test

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Tenth People's Hospital Shanghai China 200040

    Sponsors and Collaborators

    • Shanghai 10th People's Hospital

    Investigators

    • Principal Investigator: Sheng Wang, PHD, Shanghai 10th People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sheng Wang MD PhD, MD PhD, Shanghai 10th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06000618
    Other Study ID Numbers:
    • STPH-ICU-006
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sheng Wang MD PhD, MD PhD, Shanghai 10th People's Hospital
    Intrapulmonary percussive
    Healthy volunteer
    pulmonary function
    Electrical Impedance Tomography

    Study Results

    No Results Posted as of Aug 21, 2023