Respiratory Monitoring System Safety and Performance Study

NCT05812378 | Unknown

• 1 other identifier: CP-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 patient's RR, TV, MV, and end-tidal carbon dioxide concentration.

Conditions

Pulmonary Function Test; Tidal Volume; Respiratory Rate; Ventilators; Breathing Sounds

Keywords

Minute Ventilation

Outcome Measures

Primary Outcomes (9)

• 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

  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

  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

  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

  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)

  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)

  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)

  20 minutes

• Tidal volume trend

  Tidal volume trend \> 0.95 (r² correlation to pneumotach)

  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

  20 minutes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient has a history of anxiety or claustrophobia related to wearing a face mask
• Age \< 21 or \> 80 years old
• BMI \< 18 or \> 38

Sponsors & Collaborators

• RTM Vital Signs, LLC: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Torjman, PhD

  Thomas Jefferson University and Hospitals Department of Anesthesiology and Perioperative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Joseph, DO

CONTACT

215-503-8032; jeffrey.joseph@rtmvitalsigns.com

Breanna Atherton, BS

CONTACT

419-450-5645; batherton@mededge.io

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 13, 2023
• Study Start: March 24, 2023
• Primary Completion: December 9, 2023
• Study Completion: December 9, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

US (1)