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NCT04292639: RR

Vital USA Respiratory Rate Validation In Adults

Completed NA Results posted Last updated 28 May 2020
What this trial tests

NA trial testing The Vital Detect Pulse Oximeter in Respiratory Complication in 20 participants. Completed in 20 December 2019.

Timeline
17 December 2019
Primary endpoint
20 December 2019
20 December 2019

Quick facts

Lead sponsorVital USA, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment20
Start date17 December 2019
Primary completion20 December 2019
Estimated completion20 December 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vital USA, Inc.

Who can join

Adults 18 to 52, any sex, with Respiratory Complication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor. Primary · 20 Seconds

The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).The endpoint of interest was accuracy as measured by the Accuracy root-mean-square (ARMS) difference between the Device Under Test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods.

GroupValue95% CI
Respiratory Rate1.39± 1.39

Sponsor's own description

Vital USA is dedicated to developing and applying innovative electronic medical solutions that improve patient care in multiple clinical settings. Vital USA is a manufacturer of a multi-parameter patient monitor that is intended to be used in a variety of medical settings including hospitals, medical offices and patients' homes.

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:

Other recruiting trials for Respiratory Complication

Currently open trials in the same condition.

Other Vital USA, Inc. 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/NCT04292639.

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