Feasibility of a New Ambulatory Multi-vital Signs Monitor

Not Applicable

Terminated

Conditions: Perioperative/Postoperative Complications

Interventions: Device: Caretaker Device placement

Registration Number: NCT05562011

Lead Sponsor: Wake Forest University Health Sciences

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caretaker Device	Caretaker Device placement	participants will undergo active CareTaker monitoring for 24-48 hours

Primary Outcome Measures

Name	Time	Method
Monitor Return Rate	Baseline through Pre-Op Hour 24	Percent of monitors returned to our research technicians
Preoperative Caretaker Monitor Placement Success	Baseline	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.
Ease of Use Determined by Number of Participants With Sleep or Activities of Daily Living (ADLs) Interference	Pre-Op Hour 24	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.
Postoperative Caretaker Healthcare Provider (HCP) Usability	Post-Op Hour 24	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	Post-Op Hour 24	Number of participants with no missing values expressed

Secondary Outcome Measures

Name	Time	Method
Heart Rate	Pre-Op hour 24, Post-Op Hour 24
Mortality Rate	Day 30	Percent declared dead
Heart Rate--percent of Time Parameters	Pre-Op Hour 24, Post-Op Hour 24	Percentage of time heart rate is \<60 bpm or \>90 bpm
Respiratory Rate	Pre-Op hour 24, Post-Op Hour 24
SaO2--Percent of Time	Pre-Op Hour 24, Post-Op Hour 24	Percentage of time SaO2 is between 95-100%
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
Arterial Oxygen Saturation (SaO2)	Post-Op Hour 24	oxygen saturation level as detected by the pulse oximeter
Non-Invasive Systolic Blood Pressure (SBP)	Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Blood Pressure--MBP Percent of Time Parameters	Pre-Op Hour 24, Post-Op Hour 24	Percent time MBP is \<60 mmHg and/or \>90 mmHg
Number of Rapid Response Team Calls	During hospitalization up to Postoperative Day 30	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.
Respiratory Rate--Percent of Time Parameters	Pre-Op hour 24, Post-Op Hour 24	Percent of time respirations are \<8 rpm or \>20 rpm
Average Length of Hospital Stay	Up to Postoperative Day 30	Number of days from hospital admission to discharge
ICU Transfer Rate	Up to Postoperative Day 30	Percent of study participants transferred to an ICU during their hospital stay