Effects of Intrapulmonary Percussive Ventilator on Respiratory Function

Airway Clearance Impairment Clinical Trial

Official title:

Effects of Intrapulmonary Percussive Ventilator on Respiratory Function: an Experiment in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000618
• Other study ID #: STPH-ICU-006
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: Shanghai 10th People's Hospital
• Contact: Xin Jing, Dr
• Phone: +86-18917682679
• Email: lingzi_jx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Clearance Impairment

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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: 10.418 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	The treatment was scored once after the participants completed both low and high frequency intrapulmonary percussive.Up to one week.