Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05812378 |
Other study ID # |
CP-001 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 24, 2023 |
Est. completion date |
December 9, 2023 |
Study information
Verified date |
April 2023 |
Source |
RTM Vital Signs, LLC |
Contact |
Jeffrey Joseph, DO |
Phone |
215-503-8032 |
Email |
jeffrey.joseph[@]rtmvitalsigns.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The goal of this observational study is collect data to evaluate the efficacy of the RMS
system in monitoring, recording, and presenting respiratory function data to the user in
participants scheduled for pulmonary function testing (PFT).
Participants will complete:
- 60 episodes of data collection with a decreased tidal volume
- 30 episodes of data collection with an increased tidal volume
- 80 episodes with normal tidal volume breathing
The TSS will continuously transmit sound data to an adjacent personal computer (PC) via
Bluetooth Low-Energy (BLE). TSS trachea sound data will be recorded on the PC and then
transmitted via a secure wireless network to an RTM cloud account that is HIPPA compliant.
Reference breathing data will be simultaneously recorded using an FDA approved hospital
ventilator (Hamilton Medical, HAMILTON-C1) with a calibrated pneumotach, capnometer, and a
tight-fitting face mask. This system accurately measures and records a spontaneously
breathing patient's RR, TV, MV, and end-tidal carbon dioxide concentration.
Description:
Observational single-center data will be captured on up to 50 patients scheduled for
pulmonary function testing (PFT) at Thomas Jefferson University Hospital's (TJUH) outpatient
PFT facility. Plan is to record a complete data set from 30 patients. Breathing data for this
study will be collected in the PFT facility by research personnel approximately 1 hour before
or after the scheduled PFT test. Study personnel will adhere the TSS to the skin over the
proximal trachea (midline above the sternal notch). The patient's neck will be examined prior
to TSS attachment.
The TSS will continuously transmit sound data to an adjacent personal computer (PC) via
Bluetooth Low-Energy (BLE). TSS trachea sound data will be recorded on the PC and then
transmitted via a secure TJUH wireless network to an RTM cloud account that is HIPPA
compliant.
Reference breathing data will be simultaneously recorded using an FDA approved hospital
ventilator (Hamilton Medical, HAMILTON-C1) with a calibrated pneumotach, capnometer, and a
tight-fitting face mask. This FDA approved system accurately measures and records a
spontaneously breathing patient's RR, TV, MV, and end-tidal carbon dioxide concentration.
Study subjects will breathe through the HAMILTON ventilator's face mask, , capnometer, and
pneumotach over a range of RR, TV, and MV with the data recorded on a computer. Each study
subject will breathe with a normal RR, TV, and MV for approximately 5 minutes. Each subject
will then breathe with a normal RR and a decreased tidal volume for approximately 60 to 80
seconds episode (shallow breathing), followed by a rest period (normal breathing). Each
subject will then breathe with a normal RR and an increased tidal volume for approximately 60
to 80 seconds episode (deep breathing), followed by a rest period (normal breathing). This
series of breathing will take approximately 7.5 minutes to record. Each subject will complete
a second series of breathing using the identical methods. Study subjects will observe a
computer screen that displays breath- by-breath tidal volume to help them maintain their
tidal volume in the desired range during each recording.
Plan is to record and analyze approximately 280 breaths per study subject and 8,400 breaths
from the 30 study subjects.