Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812378
Status:
RECRUITING
Last Update Posted:
2023-04-13
First Post:
2023-04-02
Brief Title:
Respiratory Monitoring System Safety and Performance Study
Sponsor:
RTM Vital Signs LLC
Organization:
RTM Vital Signs LLC
Study Overview
Official Title:
Respiratory Monitoring System Safety and Performance Study
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients RR TV MV and end-tidal carbon dioxide concentration
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 patients RR TV MV and end-tidal carbon dioxide concentration
Detailed Description:
Observational single-center data will be captured on up to 50 patients scheduled for pulmonary function testing PFT at Thomas Jefferson University Hospitals 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 patients 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 patients RR TV MV and end-tidal carbon dioxide concentration
Study subjects will breathe through the HAMILTON ventilators 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 75 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 8400 breaths from the 30 study subjects
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 patients RR TV MV and end-tidal carbon dioxide concentration
Study subjects will breathe through the HAMILTON ventilators 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 75 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 8400 breaths from the 30 study subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None