Perioperative/Postoperative ComplicationsNCT05562011
Feasibility of a New Ambulatory Multi-vital Signs Monitor
A study testing Caretaker Device placement in people with Perioperative/Postoperative Complications, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Caretaker Device placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Surgery on the day of admission (same-day surgery)
- Any upper extremity surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Feasibility Study of an Ambulatory Multi-Vital Signs Monitor in Perioperative Patients
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
Read the 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.
- Being tested
- Caretaker Device placement
- Keywords
- Caretaker, wrist monitor, vital signs
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caretaker Device placementDevice
a continuous non-invasive blood pressure and vital signs monitor that is worn on the wrist
| Study group | Role | What they receive |
|---|---|---|
| Caretaker Device | Experimental | participants will undergo active CareTaker monitoring for 24-48 hours Receives: Device: Caretaker Device placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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?
Measured: Post-Op Hour 24
Caretaker Data Capture Rate
Number of participants with no missing values expressed
Measured: Pre-Op Hour 24
Caretaker Data Capture Rate
Number of participants with no missing values expressed
Measured: 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
Measured: Post-Op Hour 24
Monitor Return Rate
Percent of monitors returned to our research technicians
Measured: Baseline through Pre-Op Hour 24
Secondary outcomes (14)
Heart Rate
Measured: 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
Measured: Pre-Op Hour 24, Post-Op Hour 24
Respiratory Rate
Measured: Pre-Op hour 24, Post-Op Hour 24
Respiratory Rate--Percent of Time Parameters
Percent of time respirations are <8 rpm or >20 rpm
Measured: Pre-Op hour 24, Post-Op Hour 24
Arterial Oxygen Saturation (SaO2)
oxygen saturation level as detected by the pulse oximeter
Measured: Post-Op Hour 24
SaO2--Percent of Time
Percentage of time SaO2 is between 95-100%
Measured: Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Systolic Blood Pressure (SBP)
Measured: Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Mean Arterial Blood Pressure (MBP)
Measured: Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Diastolic Blood Pressure (DBP)
Measured: 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
Measured: Pre-Op Hour 24, Post-Op Hour 24
Mortality Rate
Percent declared dead
Measured: Day 30
Average Length of Hospital Stay
Number of days from hospital admission to discharge
Measured: Up to Postoperative Day 30
ICU Transfer Rate
Percent of study participants transferred to an ICU during their hospital stay
Measured: 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.
Measured: During hospitalization up to Postoperative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start18 Aug 2021
- Primary completion22 Sep 2022
- Study completion24 Oct 2022
Why it stopped: feasibility of device use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Caretaker device placement
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Harwood, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562011
- Sponsor's protocol ID
- IRB00073729
- Status last verified
- Sep 2023
- First submitted
- 3 Jun 2022
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of an Ambulatory Multi-Vital Signs Monitor in Perioperative Patients
- ClinicalTrials.gov ID
- NCT05562011
- Acronym / sponsor ID
- IRB00073729
- Keywords
- Caretaker, wrist monitor, vital signs
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: feasibility of device use
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Caretaker device placement
| Arm | Type | Receives |
|---|---|---|
| Caretaker Device | Experimental | Device: Caretaker Device placementparticipants will undergo active CareTaker monitoring for 24-48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caretaker Device placementa continuous non-invasive blood pressure and vital signs monitor that is worn on the wrist | Device | Caretaker Device |
Primary outcome
Preoperative Caretaker Monitor Placement Success
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-Op Hour 24
Number of participants with no missing values expressed
Caretaker Data Capture Rate
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
Number of participants with no missing values expressed
Caretaker Data Capture Rate
Time frame: Post-Op Hour 24
Number of participants with no missing values expressed
Monitor Return Rate
Time frame: Baseline through Pre-Op Hour 24
Percent of monitors returned to our research technicians
14 secondary outcomes
Heart Rate
Time frame: Pre-Op hour 24, Post-Op Hour 24
Heart Rate--percent of Time Parameters
Time frame: Pre-Op Hour 24, Post-Op Hour 24
Respiratory Rate
Time frame: Pre-Op hour 24, Post-Op Hour 24
Respiratory Rate--Percent of Time Parameters
Time frame: Pre-Op hour 24, Post-Op Hour 24
Arterial Oxygen Saturation (SaO2)
Time frame: Post-Op Hour 24
SaO2--Percent of Time
Time frame: Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Systolic Blood Pressure (SBP)
Time frame: Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Mean Arterial Blood Pressure (MBP)
Time frame: Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Diastolic Blood Pressure (DBP)
Time frame: Pre-Op Hour 24, Post-Op Hour 24
Non-Invasive Blood Pressure--MBP Percent of Time Parameters
Time frame: Pre-Op Hour 24, Post-Op Hour 24
Mortality Rate
Time frame: Day 30
Average Length of Hospital Stay
Time frame: Up to Postoperative Day 30
ICU Transfer Rate
Time frame: Up to Postoperative Day 30
Number of Rapid Response Team Calls
Time frame: During hospitalization up to Postoperative Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Harwood, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caretaker Device placement in people with Perioperative/Postoperative Complications, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Caretaker Monitor Placement Success (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.