Last reviewed · How we verify

NCT05812378

Respiratory Monitoring System Safety and Performance Study

Status unknown Last updated 13 April 2023
What this trial tests

trial in Pulmonary Function Test in 50 participants. Status unknown.

Timeline
24 March 2023
Primary endpoint
9 December 2023
9 December 2023

Quick facts

Lead sponsorRTM Vital Signs, LLC
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment50
Start date24 March 2023
Primary completion9 December 2023
Estimated completion9 December 2023
Sites1 location across United States

Conditions studied

Sponsor

RTM Vital Signs, LLC

Who can join

Adults 18 to 80, any sex, with Pulmonary Function Test or Tidal Volume. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pulmonary Function Test

Currently open trials in the same condition.

Other RTM Vital Signs, LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05812378.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing