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Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity

NCT06995742 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-06-05

No results posted yet for this study

Summary

Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor.

Conditions

  • Vital Sign Evaluation
  • Vital Sign Monitoring
  • Sleep Quality
  • Provider Behavior
  • Patient Satisfaction

Interventions

DEVICE

Device Array Use

Study participants assigned to the intervention study arm will wear a wireless Bluetooth capable vital sign detection array, with one device externally worn on each of their chest, one finger, and one arm, with healthcare providers using an additional oral temperature probe.

DEVICE

Routine Vital Sign Measurement

Study participants randomized to the control arm will have their vital signs obtained by routine means, without use of the wireless vital sign device array.

Sponsors & Collaborators

  • University of Minnesota Medical School/University of Minnesota Foundation

    collaborator UNKNOWN

  • Sibel Health Inc.

    collaborator INDUSTRY

  • Northwestern University

    lead OTHER

Principal Investigators

  • Gregory (Randy) R Smith Jr, MD MS · Northwestern University Feinberg School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06995742 on ClinicalTrials.gov