RECRUITING

Respiratory Monitoring System Safety and Performance Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Respiratory Monitoring System Safety and Performance Study

Quick Facts

Study Start:2023-03-24
Study Completion:2023-12-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05812378

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21 to ≤ 80 years
  2. * 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
  3. * Body Mass Index between 18 to 38
  4. * Subject willing and able to comply with the study procedures
  5. * 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
  1. * Subject has an active respiratory infection, unstable cardiovascular disease, severe asthma, severe bronchitis, or severe emphysema at the time of study
  2. * Recent COVID illness (must be symptom free for \> 10 days or recent COVID exposure within last 10 days
  3. * History of skin sensitivity to the sensor, adhesive, or face mask materials
  4. * Active inflammation or infection of the skin at the site of TSS attachment
  5. * Subject is pregnant or breastfeeding
  6. * Current participation in another industry sponsored drug or device study
  7. * Patient has a history of anxiety or claustrophobia related to wearing a face mask
  8. * Age \< 21 or \> 80 years old
  9. * BMI \< 18 or \> 38

Contacts and Locations

Study Contact

Jeffrey Joseph, DO
CONTACT
215-503-8032
jeffrey.joseph@rtmvitalsigns.com
Breanna Atherton, BS
CONTACT
419-450-5645
batherton@mededge.io

Principal Investigator

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

Study Locations (Sites)

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: RTM Vital Signs, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-24
Study Completion Date2023-12-09

Study Record Updates

Study Start Date2023-03-24
Study Completion Date2023-12-09

Terms related to this study

Keywords Provided by Researchers

  • Minute Ventilation

Additional Relevant MeSH Terms

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