Pulmonary Function TestNCT05812378
Respiratory Monitoring System Safety and Performance Study
An observational study of Pulmonary Function Test and Tidal Volume, run by RTM Vital Signs, LLC at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Function Test, Tidal Volume, Respiratory Rate
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2023to 9 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Approximately an equal number of male/female subjects will be studied. Approximately an equal number of subjects will be in the 21 to 40 age range, the 41 to 60 age range, and the > 60 age range. Outpatients scheduled for testing at the PFT Laboratory facility at Thomas Jefferson University Hospital will be recruited for study. Breathing data will be collected by study personnel approximately one hour before or after the scheduled PFT. All patients who meet required inclusion and exclusion criteria are eligible for enrollment.
Who may be able to join
- Age 21 to ≤ 80 years
- Subject has no active signs/symptoms of a respiratory infection, severe asthma, severe bronchitis, severe emphysema, or unstable cardiovascular disease at the time of data collection
- Body Mass Index between 18 to 38
- Subject willing and able to comply with the study procedures
- Subject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent
Who cannot join
- Subject has an active respiratory infection, unstable cardiovascular disease, severe asthma, severe bronchitis, or severe emphysema at the time of study
- Recent COVID illness (must be symptom free for > 10 days or recent COVID exposure within last 10 days
- History of skin sensitivity to the sensor, adhesive, or face mask materials
- Active inflammation or infection of the skin at the site of TSS attachment
- Subject is pregnant or breastfeeding
- Current participation in another industry sponsored drug or device study
Show all 9Show fewer
- Patient has a history of anxiety or claustrophobia related to wearing a face mask
- Age < 21 or > 80 years old
- BMI < 18 or > 38
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Jennifer Lessin, RN, 215-955-5804, Jennifer.Lessin@Jefferson.edu
Marc Torjman, PhD
About this study
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:
Read more
- 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.
Read the detailed 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.
- Keywords
- Minute Ventilation
- Medical subject headings
- Respiratory Sounds
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of RMS of the RMS system in monitoring, recording, and presenting respiratory function data to the user
The RMS measures respiratory rate, approximate/relative tidal volume, and approximate/relative minute ventilation when compared to measurements made with the HAMILTON ventilator pneumotach device
Measured: 20 minutes
Mean Measurement Accuracy Error for Respiratory Rate
Mean measurement accuracy error for RR across all subjects shall be ≤ 5 % (±1 breath/minute) compared to the pneumotach
Measured: 20 minutes
Mean Measurement Accuracy Error for Tidal Volume
Mean measurement accuracy error for TV across all subjects shall be ≤15% compared to the pneumotach
Measured: 20 minutes
Mean measurement accuracy error for Minute Ventilation
Mean measurement accuracy error for MV across all subjects shall be ≤15% compared to the pneumotach
Measured: 20 minutes
Mean measurement bias for Respiratory Rate
Mean measurement bias (RMS-pneumotach) for RR shall be < 2% (95% limits of agreement ±1.96 SD)
Measured: 20 minutes
Mean measurement bias for Tidal Volume
Mean measurement bias (RMS-pneumotach) for TV shall be < 5% (95% limits of agreement ±1.96 SD)
Measured: 20 minutes
Mean measurement bias for Minute Ventilation
Mean measurement bias (RMS-pneumotach) for MV shall be < 5% (95% limits of agreement ±1.96 SD)
Measured: 20 minutes
Tidal volume trend
Tidal volume trend > 0.95 (r² correlation to pneumotach)
Measured: 20 minutes
Mean measurement accuracy error for number of seconds since last breath
Mean measurement accuracy error for number of seconds since last breath across all subjects shall be ≤ 5 % (± 2 seconds) compared to the pneumotach
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start24 Mar 2023
- Primary completion9 Dec 2023 (estimated)
- Study completion9 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Function TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTM Vital Signs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Torjman, PhD, Principal investigator, Thomas Jefferson University and Hospitals Department of Anesthesiology and Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812378
- Sponsor's protocol ID
- CP-001
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Monitoring System Safety and Performance Study
- ClinicalTrials.gov ID
- NCT05812378
- Acronym / sponsor ID
- CP-001
- Keywords
- Minute Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RTM Vital Signs, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 9 Dec 2023 (estimated)
- Study completion
- 9 Dec 2023 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Approximately an equal number of male/female subjects will be studied. Approximately an equal number of subjects will be in the 21 to 40 age range, the 41 to 60 age range, and the > 60 age range. Outpatients scheduled for testing at the PFT Laboratory facility at Thomas Jefferson University Hospital will be recruited for study. Breathing data will be collected by study personnel approximately one hour before or after the scheduled PFT. All patients who meet required inclusion and exclusion criteria are eligible for enrollment.
Key inclusion criteria (5 listed)
- Age 21 to ≤ 80 years
- Subject has no active signs/symptoms of a respiratory infection, severe asthma, severe bronchitis, severe emphysema, or unstable cardiovascular disease at the time of data collection
- Body Mass Index between 18 to 38
- Subject willing and able to comply with the study procedures
- Subject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent
Key exclusion criteria (9 listed)
- Subject has an active respiratory infection, unstable cardiovascular disease, severe asthma, severe bronchitis, or severe emphysema at the time of study
- Recent COVID illness (must be symptom free for > 10 days or recent COVID exposure within last 10 days
- History of skin sensitivity to the sensor, adhesive, or face mask materials
- Active inflammation or infection of the skin at the site of TSS attachment
- Subject is pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of RMS of the RMS system in monitoring, recording, and presenting respiratory function data to the user
Time frame: 20 minutes
The RMS measures respiratory rate, approximate/relative tidal volume, and approximate/relative minute ventilation when compared to measurements made with the HAMILTON ventilator pneumotach device
Mean Measurement Accuracy Error for Respiratory Rate
Time frame: 20 minutes
Mean measurement accuracy error for RR across all subjects shall be ≤ 5 % (±1 breath/minute) compared to the pneumotach
Mean Measurement Accuracy Error for Tidal Volume
Time frame: 20 minutes
Mean measurement accuracy error for TV across all subjects shall be ≤15% compared to the pneumotach
Mean measurement accuracy error for Minute Ventilation
Time frame: 20 minutes
Mean measurement accuracy error for MV across all subjects shall be ≤15% compared to the pneumotach
Mean measurement bias for Respiratory Rate
Time frame: 20 minutes
Mean measurement bias (RMS-pneumotach) for RR shall be < 2% (95% limits of agreement ±1.96 SD)
Mean measurement bias for Tidal Volume
Time frame: 20 minutes
Mean measurement bias (RMS-pneumotach) for TV shall be < 5% (95% limits of agreement ±1.96 SD)
Mean measurement bias for Minute Ventilation
Time frame: 20 minutes
Mean measurement bias (RMS-pneumotach) for MV shall be < 5% (95% limits of agreement ±1.96 SD)
Tidal volume trend
Time frame: 20 minutes
Tidal volume trend > 0.95 (r² correlation to pneumotach)
Mean measurement accuracy error for number of seconds since last breath
Time frame: 20 minutes
Mean measurement accuracy error for number of seconds since last breath across all subjects shall be ≤ 5 % (± 2 seconds) compared to the pneumotach
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Torjman, PhD principal investigator
Thomas Jefferson University and Hospitals Department of Anesthesiology and Perioperative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Function Test and Tidal Volume, run by RTM Vital Signs, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Joseph, DO (215-503-8032, jeffrey.joseph@rtmvitalsigns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of RMS of the RMS system in monitoring, recording, and presenting respiratory function data to the user (time frame: 20 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.