Feasibility of a New Ambulatory Multi-vital Signs Monitor

NCT ID: NCT05562011

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2022-10-24

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. 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

Detailed Description

Anesthesiologists and surgeons examine vital signs such as heart rate (HR), respiratory rate (RR), oxygen saturation (SaO2) and blood pressure (BP) in an effort to detect extremes of altered VS and remediate these alterations prior to surgery and anesthesia. In most preoperative clinics, however, these VS are measured once and no further assessments are made until they arrive for their surgery. Patients with cardiac and pulmonary disease, however, can have highly variable VS.

The Caretaker device is a wrist device designed to measure relatively continuous VS over a period up to 24 hours. The device is accompanied by a finger cuff that measure pulse and respiratory rate, along with a non-invasive blood pressure detector and pulse oximeter. In an effort to detect VS that may not be recognized with the usual one-time measurement in the clinic, the study team plans to monitor ambulatory preoperative VS in patients who meet the study criteria, for up to 16-24 hours preoperatively. They will then return their device on the day of surgery.

Postoperatively, the study team will place a CareTaker device once again and measure these same VS in the same patients for up to 24 hours prior to discharge.

Conditions

Perioperative/Postoperative Complications

Keywords

Caretaker; wrist monitor; vital signs

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Caretaker Device

participants will undergo active CareTaker monitoring for 24-48 hours

Group Type: EXPERIMENTAL

Caretaker Device placement

Intervention Type: DEVICE

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

Interventions

Caretaker Device placement

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Harwood, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00073729

Identifier Type: -

Identifier Source: org_study_id