Respiratory Monitoring System Safety and Performance Study
Public ClinicalTrials.gov record NCT05812378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05812378
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 50 participants
Conditions and interventions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 23, 2023
- Primary completion
- Dec 8, 2023
- Completion
- Dec 8, 2023
- Last update posted
- Apr 12, 2023
2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05812378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2023 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05812378 live on ClinicalTrials.gov.