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Respiratory Monitoring System Safety and Performance Study

NCT05812378 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-04-13

No results posted yet for this study

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

Sponsors & Collaborators

  • RTM Vital Signs, LLC

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2023-12-09
Completion
2023-12-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812378 on ClinicalTrials.gov