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Feasibility of a New Ambulatory Multi-vital Signs Monitor

NCT05562011 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-12-20

Study results available
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Summary

The purpose of this research is evaluate vital signs (VS), which include non-invasive blood pressure, pulse rate, respiratory rate and Oxygen Saturation (SpO2) using a portable wrist monitoring device called a Caretaker. This device has been cleared by the Food and Drug Administration (FDA) for use and allows the study team to check vital signs in a participant's normal setting.

Participation in this study will involve wearing this portable device at 2 different time points:

1. for up to 24 hours immediately during and after the participant's preoperative visit to obtain baseline vital signs during normal activity and during sleep and
2. after surgery up to 24 hours while participant recovers prior to discharge from the hospital

Conditions

  • Perioperative/Postoperative Complications

Interventions

DEVICE

Caretaker Device placement

a continuous non-invasive blood pressure and vital signs monitor that is worn on the wrist

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Timothy Harwood, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2022-09-22
Completion
2022-10-24
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05562011 on ClinicalTrials.gov