Respiratory Monitoring System Safety and Performance Study

Description

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

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Study Overview

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Study Details

Study overview

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.

Respiratory Monitoring System Safety and Performance Study

Respiratory Monitoring System Safety and Performance Study

Condition
Pulmonary Function Test
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

RTM Vital Signs, LLC,

Marc Torjman, PhD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University and Hospitals Department of Anesthesiology and Perioperative Medicine

Study Record Dates

2023-12-09