Feasibility of a New Ambulatory Multi-vital Signs Monitor

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Perioperative/Postoperative Complications

Intervention / Treatment
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* Device: Caretaker Device placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Caretaker device placement
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate |  | Pre-Op hour 24, Post-Op Hour 24 | 
| 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 | 
| 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 | 
| 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 | 
| Average Length of Hospital Stay | Number of days from hospital admission to discharge | Up to Postoperative Day 30 | 
| ICU Transfer Rate | Percent of study participants transferred to an ICU during their hospital stay | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caretaker, wrist monitor, vital signs