Clinical trial NCT05562011: 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
Overall status: TERMINATED
Phase: NA
Conditions: Perioperative/Postoperative Complications
Keywords: Caretaker
wrist monitor
vital signs
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Caretaker device placement
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Preoperative Caretaker Monitor Placement Success
timeFrame: Baseline
measure: Ease of Use Determined by Number of Participants With Sleep or Activities of Daily Living (ADLs) Interference
timeFrame: Pre-Op Hour 24
measure: Postoperative Caretaker Healthcare Provider (HCP) Usability
timeFrame: Post-Op Hour 24
measure: Caretaker Data Capture Rate
timeFrame: Pre-Op Hour 24
measure: Caretaker Data Capture Rate
timeFrame: 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
measure: Caretaker Data Capture Rate
timeFrame: Post-Op Hour 24
measure: Monitor Return Rate
timeFrame: Baseline through Pre-Op Hour 24
Secondary outcomes:
measure: Heart Rate
timeFrame: Pre-Op hour 24, Post-Op Hour 24
measure: Heart Rate--percent of Time Parameters
timeFrame: Pre-Op Hour 24, Post-Op Hour 24
measure: Respiratory Rate
timeFrame: Pre-Op hour 24, Post-Op Hour 24
measure: Respiratory Rate--Percent of Time Parameters
timeFrame: Pre-Op hour 24, Post-Op Hour 24
measure: Arterial Oxygen Saturation (SaO2)
timeFrame: Post-Op Hour 24
measure: SaO2--Percent of Time
timeFrame: Pre-Op Hour 24, Post-Op Hour 24
measure: Non-Invasive Systolic Blood Pressure (SBP)
timeFrame: Pre-Op Hour 24, Post-Op Hour 24
measure: Non-Invasive Mean Arterial Blood Pressure (MBP)
timeFrame: Pre-Op Hour 24, Post-Op Hour 24
measure: Non-Invasive Diastolic Blood Pressure (DBP)
timeFrame: Pre-Op Hour 24, Post-Op Hour 24
measure: Non-Invasive Blood Pressure--MBP Percent of Time Parameters
timeFrame: Pre-Op Hour 24, Post-Op Hour 24
measure: Mortality Rate
timeFrame: Day 30
measure: Average Length of Hospital Stay
timeFrame: Up to Postoperative Day 30
measure: ICU Transfer Rate
timeFrame: Up to Postoperative Day 30
measure: Number of Rapid Response Team Calls
timeFrame: During hospitalization up to Postoperative Day 30
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Timothy Harwood, MD
role: PRINCIPAL_INVESTIGATOR
References: