Perioperative/Postoperative Complications
Conditions
Keywords
Caretaker, wrist monitor, vital signs
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.
Interventions
a continuous non-invasive blood pressure and vital signs monitor that is worn on the wrist
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Caretaker device placement
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pre-Op Hour 24 | Number of participants with no missing values expressed |
| Monitor Return Rate | Baseline through Pre-Op Hour 24 | Percent of monitors returned to our research technicians |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SaO2--Percent of Time | Pre-Op Hour 24, Post-Op Hour 24 | Percentage of time SaO2 is between 95-100% |
| 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 | — |
| 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 |
| Mortality Rate | Day 30 | Percent declared dead |
| 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 |
| 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. |
| 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 |
| 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 | Pre-Op hour 24, Post-Op Hour 24 | Percent of time respirations are \<8 rpm or \>20 rpm |
| Arterial Oxygen Saturation (SaO2) | Post-Op Hour 24 | oxygen saturation level as detected by the pulse oximeter |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caretaker Device Placement Caretaker Device placement: placement of the Caretaker device at preanesthesia visit and again postoperatively | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Could not co-enroll with other research study--device could not be placed postop | 1 |
| Overall Study | Device malfunction | 13 |
| Overall Study | Device not placed postop due to patient being discharged home after surgery (not staying overnight) | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Caretaker Device Placement |
|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 14.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 61 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
Primary
Caretaker Data Capture Rate
Number of participants with no missing values expressed
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, an average of 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caretaker Device | Caretaker Data Capture Rate | 39 Participants |
Primary
Caretaker Data Capture Rate
Number of participants with no missing values expressed
Time frame: Post-Op Hour 24
Population: data not collected
Primary
Caretaker Data Capture Rate
Number of participants with no missing values expressed
Time frame: Pre-Op Hour 24
Population: data not collected
Primary
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.
Time frame: Pre-Op Hour 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caretaker Device | Ease of Use Determined by Number of Participants With Sleep or Activities of Daily Living (ADLs) Interference | 16 Participants |
Primary
Monitor Return Rate
Percent of monitors returned to our research technicians
Time frame: Baseline through Pre-Op Hour 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caretaker Device | Monitor Return Rate | 61 Participants |
Primary
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?
Time frame: Post-Op Hour 24
Population: Data not collected
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caretaker Device | Preoperative Caretaker Monitor Placement Success | 39 Participants |
Secondary
Arterial Oxygen Saturation (SaO2)
oxygen saturation level as detected by the pulse oximeter
Time frame: Post-Op Hour 24
Population: data not collected
Secondary
Average Length of Hospital Stay
Number of days from hospital admission to discharge
Time frame: Up to Postoperative Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caretaker Device | Average Length of Hospital Stay | 3.5 number of days | Standard Deviation 4.3 |
Secondary
Heart Rate
Time frame: Pre-Op hour 24, Post-Op Hour 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caretaker Device | Heart Rate | Pre-Op Hour 24 | 94 beats per minute | Standard Deviation 19 |
| Caretaker Device | Heart Rate | Post-Op Hour 24 | 87 beats per minute | Standard Deviation 15 |
Secondary
Heart Rate--percent of Time Parameters
Percentage of time heart rate is \<60 bpm or \>90 bpm
Time frame: Pre-Op Hour 24, Post-Op Hour 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caretaker Device | Heart Rate--percent of Time Parameters | Pre-Op Hour 24 | 55 percentage of time | Standard Deviation 3 |
| Caretaker Device | Heart Rate--percent of Time Parameters | Post-Op Hour 24 | 40 percentage of time | Standard Deviation 4 |
Secondary
ICU Transfer Rate
Percent of study participants transferred to an ICU during their hospital stay
Time frame: Up to Postoperative Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caretaker Device | ICU Transfer Rate | 10 Participants |
Secondary
Mortality Rate
Percent declared dead
Time frame: Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caretaker Device | Mortality Rate | 0 Participants |
Secondary
Non-Invasive Blood Pressure--MBP Percent of Time Parameters
Percent time MBP is \<60 mmHg and/or \>90 mmHg
Time frame: Pre-Op Hour 24, Post-Op Hour 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caretaker Device | Non-Invasive Blood Pressure--MBP Percent of Time Parameters | Pre-Op Hour 24 | 37 percentage of time | Standard Deviation 4 |
| Caretaker Device | Non-Invasive Blood Pressure--MBP Percent of Time Parameters | Post-Op Hour 24 | 67 percentage of time | Standard Deviation 1 |
Secondary
Non-Invasive Diastolic Blood Pressure (DBP)
Time frame: Pre-Op Hour 24, Post-Op Hour 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caretaker Device | Non-Invasive Diastolic Blood Pressure (DBP) | Pre-Op Hour 24 | 58 mm of Hg | Standard Deviation 16 |
| Caretaker Device | Non-Invasive Diastolic Blood Pressure (DBP) | Post-Op Hour 24 | 68 mm of Hg | Standard Deviation 16 |
Secondary
Non-Invasive Mean Arterial Blood Pressure (MBP)
Time frame: Pre-Op Hour 24, Post-Op Hour 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caretaker Device | Non-Invasive Mean Arterial Blood Pressure (MBP) | Pre-Op Hour 24 | 82 mm of Hg | Standard Deviation 18 |
| Caretaker Device | Non-Invasive Mean Arterial Blood Pressure (MBP) | Post-Op Hour 24 | 97 mm of Hg | Standard Deviation 21 |
Secondary
Non-Invasive Systolic Blood Pressure (SBP)
Time frame: Pre-Op Hour 24, Post-Op Hour 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caretaker Device | Non-Invasive Systolic Blood Pressure (SBP) | Pre-Op Hour 24 | 119 units of millimeters of mercury (mmHg) | Standard Deviation 22 |
| Caretaker Device | Non-Invasive Systolic Blood Pressure (SBP) | Post-Op Hour 24 | 134 units of millimeters of mercury (mmHg) | Standard Deviation 24 |
Secondary
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.
Time frame: During hospitalization up to Postoperative Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caretaker Device | Number of Rapid Response Team Calls | 2 calls |
Secondary
Respiratory Rate
Time frame: Pre-Op hour 24, Post-Op Hour 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caretaker Device | Respiratory Rate | Pre-Op Hour 24 | 17 respirations per minute | Standard Deviation 4 |
| Caretaker Device | Respiratory Rate | Post-Op Hour 24 | 17 respirations per minute | Standard Deviation 4 |
Secondary
Respiratory Rate--Percent of Time Parameters
Percent of time respirations are \<8 rpm or \>20 rpm
Time frame: Pre-Op hour 24, Post-Op Hour 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caretaker Device | Respiratory Rate--Percent of Time Parameters | Pre-Op Hour 24 | 21.6 percentage of time | Standard Deviation 3.8 |
| Caretaker Device | Respiratory Rate--Percent of Time Parameters | Post-Op Hour 24 | 15.9 percentage of time | Standard Deviation 3.5 |
Secondary
SaO2--Percent of Time
Percentage of time SaO2 is between 95-100%
Time frame: Pre-Op Hour 24, Post-Op Hour 24
Population: data not collected for either time point