Feasibility of a New Ambulatory Multi-vital Signs Monitor

NCT05562011 | Terminated Results FDA Device

• 1 other identifier: IRB00073729
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.after surgery up to 24 hours while participant recovers prior to discharge from the hospital

Conditions

Perioperative/Postoperative Complications

Keywords

Caretaker; wrist monitor; vital signs

Outcome Measures

Primary Outcomes (7)

• Preoperative Caretaker Monitor Placement Success

  Number of participants who had the presence of (data existing for at least 70% of 5-minute time periods) for all of the vital signs of interest together--heart rate (HR), blood pressure (BP), respiratory rate (RR), arterial oxygen saturation (SaO2) after placement of the device on the subject's wrist and hand.

  Baseline

• Ease of Use Determined by Number of Participants With Sleep or Activities of Daily Living (ADLs) Interference

  Participants' description of ease of use (interfered with Activities of Daily Living (ADLs) or sleep) in Yes/No format. Data will be collected to demonstrate percent of patients who answered "Yes" to Sleep or ADL interference. Free text will also be recorded for qualitative purposes. Shows Caretaker Feasibility.

  Pre-Op Hour 24

• Postoperative Caretaker Healthcare Provider (HCP) Usability

  Using postoperative nurse verbal feedback on usability of the Caretaker monitor on subjects scheduled for surgery during the perioperative period. Percent of nurses who answer yes to the question: Did you have any difficulty using the Caretaker monitor?

  Post-Op Hour 24

• Caretaker Data Capture Rate

  Number of participants with no missing values expressed

  Pre-Op Hour 24

• Caretaker Data Capture Rate

  Number of participants with no missing values expressed

  Intraoperative; from the time the Operating Room monitors are placed on the patient until they come off at the end of the case, an average of 2 hours

• Caretaker Data Capture Rate

  Number of participants with no missing values expressed

  Post-Op Hour 24

• Monitor Return Rate

  Percent of monitors returned to our research technicians

  Baseline through Pre-Op Hour 24

Secondary Outcomes (14)

• Heart Rate

  Pre-Op hour 24, Post-Op Hour 24

• Heart Rate--percent of Time Parameters

  Pre-Op Hour 24, Post-Op Hour 24

• Respiratory Rate

  Pre-Op hour 24, Post-Op Hour 24

• Respiratory Rate--Percent of Time Parameters

  Pre-Op hour 24, Post-Op Hour 24

• Arterial Oxygen Saturation (SaO2)

  Post-Op Hour 24

Study Arms (1)

Caretaker Device

EXPERIMENTAL

participants will undergo active CareTaker monitoring for 24-48 hours

Device: Caretaker Device placement

Interventions

Caretaker Device placement DEVICE

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

Caretaker Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• Scheduled for surgery from an outpatient setting and scheduled for a pre-admission PAC appointment
• Risk stratification placing them in the top 25th percentile using our internally-validated PAC Risk Score.

You may not qualify if:

• Surgery on the day of admission (same-day surgery)
• Any upper extremity surgery

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Timothy Harwood, M.D.
• Organization: Wake Forest University School of Medicine

tharwood@wakehealth.edu

336.716.8830

Study Officials

• Timothy Harwood, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Caretaker device placement

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: September 30, 2022
• Study Start: August 18, 2021
• Primary Completion: September 22, 2022
• Study Completion: October 24, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)