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NCT03332147
Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients
NA trial testing Investigational Group in Vital Sign Monitoring in 80 participants. Completed in 30 June 2018.
25 May 2018
Quick facts
| Lead sponsor | Darma Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 80 |
| Start date | 4 November 2017 |
| Primary completion | 25 May 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Investigational Group
- reference group-Earlysense system
Conditions studied
- Vital Sign Monitoring — all drugs for Vital Sign Monitoring →
Sponsor
Darma Inc.
Who can join
Eligibility, any sex, with Vital Sign Monitoring. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study compares both of the investigational device and reference device to the gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each of the overall mean roots mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor is evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03332147
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Investigational Group
Trials testing the same drug.
- NCT03269643 — Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients · NA · completed
- NCT03257956 — Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients · NA · completed
Other recruiting trials for Vital Sign Monitoring
Currently open trials in the same condition.
- NCT07385092 — Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery · NA · recruiting
- NCT06995742 — Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity · NA · recruiting
- NCT06836947 — The Effect of Two Different Bathing Methods on Vital Signs and Comfort in PICU:Bath Trial · recruiting
Other Darma Inc. trials
Trials by the same sponsor.
- NCT03356184 — Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients · NA · completed
- NCT03269643 — Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients · NA · completed
- NCT03257956 — Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients · NA · completed
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 NCT03332147 (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 Darma Inc.
- Last refreshed: 11 April 2019
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/NCT03332147.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing