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Feasibility of a New Ambulatory Multi-vital Signs Monitor

Primary Purpose

Perioperative/Postoperative Complications

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caretaker Device placement
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Perioperative/Postoperative Complications focused on measuring Caretaker, wrist monitor, vital signs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Wake Forest Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caretaker Device placement

Arm Description

Outcomes

Primary Outcome Measures

Preoperative Caretaker Monitor Placement Success
This is measured by 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.
Preoperative Caretaker Feasibility--Ease of Use
Record subjects' verbal description of ease of use while the Caretaker monitor is deployed on them during a 18-24 hour preoperative ambulatory monitoring session. 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.
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?
Caretaker Data Capture Rate
No missing values expressed as percent of total time monitor is deployed) for the various periods of measurement.
Caretaker Data Capture Rate
No missing values expressed as percent of total time monitor is deployed) for the various periods of measurement.
Caretaker Data Capture Rate
No missing values expressed as percent of total time monitor is deployed) for the various periods of measurement.
Monitor Return Rate
Percent of monitors returned to our research technicians.

Secondary Outcome Measures

Heart Rate
Heart Rate--Percent of Time Parameters
Percent of time heart rate is <60 bpm or >90 bpm
Respiratory Rate
Respiratory Rate--Percent of Time Parameters
Percent of time respirations are <8 rpm or >20 rpm
Arterial Oxygen Saturation (SaO2)
SaO2--Percent of Time
Percent of time with < 90% SaO2
Non-Invasive Systolic Blood Pressure (SBP)
Non-Invasive Mean Arterial Blood Pressure (MBP)
Non-Invasive Diastolic Blood Pressure (DBP)
Non-Invasive Blood Pressure--MBP Percent of Time Parameters
Percent time MBP is <60 mmHg and/or >90 mmHg
30-day Mortality Rate
Percent of patients declared dead
Average Length of Hospital Stay
Number of days from hospital admission to discharge
ICU transfer rate
Percent of study subjects transferred to an ICU during their hospital stay
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.

Full Information

First Posted
June 3, 2022
Last Updated
September 28, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05562011
Brief Title
Feasibility of a New Ambulatory Multi-vital Signs Monitor
Official Title
A Pilot Feasibility Study of an Ambulatory Multi-Vital Signs Monitor in Perioperative Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
feasibility of device use
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications
Keywords
Caretaker, wrist monitor, vital signs

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Caretaker device placement
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caretaker Device placement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Caretaker Device placement
Intervention Description
placement of the Caretaker device at preanesthesia visit and again postoperatively
Primary Outcome Measure Information:
Title
Preoperative Caretaker Monitor Placement Success
Description
This is measured by 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.
Time Frame
Baseline
Title
Preoperative Caretaker Feasibility--Ease of Use
Description
Record subjects' verbal description of ease of use while the Caretaker monitor is deployed on them during a 18-24 hour preoperative ambulatory monitoring session. 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.
Time Frame
Pre-Op Hour 24
Title
Postoperative Caretaker Healthcare Provider (HCP) Usability
Description
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?
Time Frame
Post-Op Hour 24
Title
Caretaker Data Capture Rate
Description
No missing values expressed as percent of total time monitor is deployed) for the various periods of measurement.
Time Frame
Pre-Op Hour 24
Title
Caretaker Data Capture Rate
Description
No missing values expressed as percent of total time monitor is deployed) for the various periods of measurement.
Time Frame
Intraoperative; from the time the Operating Room monitors are placed on the patient until they come off at the end of the case.
Title
Caretaker Data Capture Rate
Description
No missing values expressed as percent of total time monitor is deployed) for the various periods of measurement.
Time Frame
Post-Op Hour 24
Title
Monitor Return Rate
Description
Percent of monitors returned to our research technicians.
Time Frame
Baseline through Pre-Op Hour 24
Secondary Outcome Measure Information:
Title
Heart Rate
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
Heart Rate--Percent of Time Parameters
Description
Percent of time heart rate is <60 bpm or >90 bpm
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
Respiratory Rate
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
Respiratory Rate--Percent of Time Parameters
Description
Percent of time respirations are <8 rpm or >20 rpm
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
Arterial Oxygen Saturation (SaO2)
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
SaO2--Percent of Time
Description
Percent of time with < 90% SaO2
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
Non-Invasive Systolic Blood Pressure (SBP)
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
Non-Invasive Mean Arterial Blood Pressure (MBP)
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
Non-Invasive Diastolic Blood Pressure (DBP)
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
Non-Invasive Blood Pressure--MBP Percent of Time Parameters
Description
Percent time MBP is <60 mmHg and/or >90 mmHg
Time Frame
Pre-Op hour 24, Post-Op Hour 24
Title
30-day Mortality Rate
Description
Percent of patients declared dead
Time Frame
Postoperative Day 30
Title
Average Length of Hospital Stay
Description
Number of days from hospital admission to discharge
Time Frame
Up to Postoperative Day 30
Title
ICU transfer rate
Description
Percent of study subjects transferred to an ICU during their hospital stay
Time Frame
Up to Postoperative Day 30
Title
Number of Rapid Response Team Calls
Description
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.
Time Frame
During hospitalization up to Postoperative Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Harwood, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of a New Ambulatory Multi-vital Signs Monitor

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