Last reviewed · How we verify
NCT05812378
Respiratory Monitoring System Safety and Performance Study
trial in Pulmonary Function Test in 50 participants. Status unknown.
9 December 2023
Quick facts
| Lead sponsor | RTM Vital Signs, LLC |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 24 March 2023 |
| Primary completion | 9 December 2023 |
| Estimated completion | 9 December 2023 |
| Sites | 1 location across United States |
Conditions studied
- Pulmonary Function Test — all drugs for Pulmonary Function Test →
- Tidal Volume — all drugs for Tidal Volume →
- Respiratory Rate — all drugs for Respiratory Rate →
- Ventilators — all drugs for Ventilators →
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.
Verify or expand the search:
- PubMed search for NCT05812378
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pulmonary Function Test
Currently open trials in the same condition.
- NCT06415890 — Effect of 4-7-8 Breathıng Technıque on Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholesectectomy · NA · recruiting
Other RTM Vital Signs, LLC trials
Trials by the same sponsor.
- NCT03845699 — Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05812378 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RTM Vital Signs, LLC
- Last refreshed: 13 April 2023
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