MedTrace Logo

Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (VERDICT-2)

NCT05886153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-06-03

No results posted yet for this study

Summary

The VERDICT-2 verification study will examine the accuracy of the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with healthy participants. The objective is to determine the accuracy of continuous non-invasive vital signs metrics including respiration, pulse rate, oxyhemoglobin saturation (SpO2), core temperature, heart rate, and cNIBP against standard comparator devices guided by consensus standards.

Conditions

  • Blood Pressure
  • Respiration
  • Pulse Rate
  • Oxygen Saturation
  • Temperature
  • Heart Rate

Interventions

DEVICE

Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

Measurements recorded by the Vitaliti CVSM device will be compared to the recordings from various standardized comparator devices.

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Population Health Research Institute

    collaborator OTHER

  • Cloud DX Inc.

    collaborator INDUSTRY

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Maura Marcucci, M.D., MSc · McMaster University, Population Health Research Institute

  • Michael McGillion, PhD · McMaster University, Population Health Research Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2023-09-19
Completion
2023-09-19

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05886153 on ClinicalTrials.gov