Feasibility of a New Ambulatory Multi-vital Signs Monitor

A Pilot Feasibility Study of an Ambulatory Multi-Vital Signs Monitor in Perioperative Patients

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

Study Overview

• Status: Terminated
• Conditions: Perioperative/Postoperative Complications
• Intervention / Treatment: Device: Caretaker Device placement

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caretaker Device; participants will undergo active CareTaker monitoring for 24-48 hours	Device: Caretaker Device placement; a continuous non-invasive blood pressure and vital signs monitor that is worn on the wrist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate		Pre-Op hour 24, Post-Op Hour 24
Respiratory Rate		Pre-Op hour 24, Post-Op Hour 24
Respiratory Rate--Percent of Time Parameters	Percent of time respirations are <8 rpm or >20 rpm	Pre-Op hour 24, Post-Op Hour 24
Average Length of Hospital Stay	Number of days from hospital admission to discharge	Up to Postoperative Day 30
Number of Rapid Response Team Calls	Number of calls made to the hospital's "Rapid Response Team" (RRT) during subjects' hospital stay. The RRT is called by nurses if the patient is experiencing stroke-like symptoms, chest pain refractory to medical treatment, or vital signs (HR, RR, BP, SaO2) meeting a pre-defined out of range value.	During hospitalization up to Postoperative Day 30
Heart Rate--percent of Time Parameters	Percentage of time heart rate is <60 bpm or >90 bpm	Pre-Op Hour 24, Post-Op Hour 24
Arterial Oxygen Saturation (SaO2)	oxygen saturation level as detected by the pulse oximeter	Post-Op Hour 24
SaO2--Percent of Time	Percentage of time SaO2 is between 95-100%	Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Systolic Blood Pressure (SBP)		Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Mean Arterial Blood Pressure (MBP)		Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Diastolic Blood Pressure (DBP)		Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Blood Pressure--MBP Percent of Time Parameters	Percent time MBP is <60 mmHg and/or >90 mmHg	Pre-Op Hour 24, Post-Op Hour 24
Mortality Rate	Percent declared dead	Day 30
ICU Transfer Rate	Percent of study participants transferred to an ICU during their hospital stay	Up to Postoperative Day 30

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Timothy Harwood, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): October 24, 2022

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: vital signs; Caretaker; wrist monitor
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: IRB00073729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes