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The study team will collect data for this study from participants who are having surgery and recovering postoperatively on 2 pre-designated hospital units. The study team will use vital signs data from a portable device that participants wear on their wrists as well as conventional vital signs data that is collected when a health care provider comes into their room and collect this information.
A substudy is also being performed with the distribution of surveys to the nursing staff on the floors who are utilizing the ViSi hemodynamic monitors within our institution.
This proposed study will provide the necessary preliminary data for a National Institutes of Health Research Grant Project (NIH R01) application that will test the utility of continuous portable hemodynamic monitoring in a large-scale randomized trial. Two separate post surgical hospital units will be randomized to utilize the Sotera ViSi monitoring system or to not utilize the Sotera ViSi monitoring system for a 4 week period of time alternating over the period of 1 year. The study team will assess the effect of unblinded continuous monitoring and the associated alerts on the cumulative duration (min/hour) of each of hypotension, tachycardia, and desaturation. The study team will assess the effect of continuous monitoring and associated alerts on the ordinal clinical intervention outcome which measures the single most extreme/elevated clinical intervention incurred by a patient for any of the 3 outcome variables of interest (hypotension, tachycardia, hypoxia) during the study period with response by staff. The study team will assess the treatment effect on myocardial injury after non-cardiac surgery (MINS) during the study period.
A substudy involving the the medical center nursing staffs' impressions of the device as well as their confidence in its utilization in keeping their assigned patient's safe will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded Ward | Active Comparator | Continuous ward monitoring with hallway monitor screens covered. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered.Continuous monitoring accessible to clinicians with pre-specified alerts at Systolic Blood Pressure alert <70, no Mean Arterial Pressure alert, heart rate >150 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <80%. Every 4 hourly checks by nursing teams unless otherwise ordered. These alarms are consistent with current standard of care. |
|
| Unblinded Ward | Experimental | Continuous ward monitoring with hallway monitor screens accessible for viewing but with alarm limits more narrow. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will be able to view the hallway monitors showing the vital signs in all of the rooms and/or log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered. Continuous monitoring accessible to clinicians with pre-specified alerts at Mean Arterial Pressure (MAP) <65 mmHg, heart rate >110 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <90%. Every 4 hourly checks by nursing teams unless otherwise ordered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViSi device | Device | Mobile patient monitoring system for vital signs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hypotension in Minutes | Hypotension defined as MAP <65 mmHg. | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
| Duration of Tachycardia in Minutes | Tachycardia defined as >110 beats/min. | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
| Duration of Hypoxemia (SpO2 < 90%) in Minutes | Duration of Hypoxemia defined as SpO2 < 90% in Minutes | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Nursing Intervention Responses Scale | Clinical nursing intervention responses over the duration of the trial will be categorized as (1) none, (2) independent nursing intervention, (3) notification of physician team, or (4) activation of the hospital Emergency or Rapid Response System. Scale ranges from 1-4 with 4 denoting a worse outcome. | Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS) | Determined by blood troponin levels. Concentrations ≥0.03 ng/ml will be considered MINS if there is no evidence of a non-ischemic etiology. | Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashish Khanna, M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Univesity Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41885865 | Derived | Khanna AK, O'Connell NS, Saha AK, Hicks MH, Weller RS, Harris L, Cusson BD, Faris A, Huffman CS, Segal S, Wells BJ, Kirkendall ES, Sessler DI. Continuous vs Intermittent Postoperative Vital Sign Monitoring: A Cluster Randomized Crossover Trial. JAMA Netw Open. 2026 Mar 2;9(3):e263290. doi: 10.1001/jamanetworkopen.2026.3290. |
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All of the IPD collected during the course of the study will be deidentified and then analyzed
immediately following publication. No end date available.
any purpose
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| ID | Title | Description |
|---|---|---|
| FG000 | Blinded Ward | Continuous ward monitoring with hallway monitor screens covered. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered.Continuous monitoring accessible to clinicians with pre-specified alerts at Systolic Blood Pressure alert <70, no Mean Arterial Pressure alert, heart rate >150 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <80%. Every 4 hourly checks by nursing teams unless otherwise ordered. These alarms are consistent with current standard of care. ViSi device: Mobile patient monitoring system for vital signs. |
| FG001 | Unblinded Ward | Continuous ward monitoring with hallway monitor screens accessible for viewing but with alarm limits more narrow. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will be able to view the hallway monitors showing the vital signs in all of the rooms and/or log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered. Continuous monitoring accessible to clinicians with pre-specified alerts at Mean Arterial Pressure (MAP) <65 mmHg, heart rate >110 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <90%. Every 4 hourly checks by nursing teams unless otherwise ordered. ViSi device: Mobile patient monitoring system for vital signs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blinded Ward | Continuous ward monitoring with hallway monitor screens covered. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered.Continuous monitoring accessible to clinicians with pre-specified alerts at Systolic Blood Pressure alert <70, no Mean Arterial Pressure alert, heart rate >150 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <80%. Every 4 hourly checks by nursing teams unless otherwise ordered. These alarms are consistent with current standard of care. ViSi device: Mobile patient monitoring system for vital signs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Hypotension in Minutes | Hypotension defined as MAP <65 mmHg. | Posted | Median | Inter-Quartile Range | Minutes | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
|
Hour 72
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinded Ward | Continuous ward monitoring with hallway monitor screens covered. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered.Continuous monitoring accessible to clinicians with pre-specified alerts at Systolic Blood Pressure alert <70, no Mean Arterial Pressure alert, heart rate >150 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <80%. Every 4 hourly checks by nursing teams unless otherwise ordered. These alarms are consistent with current standard of care. ViSi device: Mobile patient monitoring system for vital signs. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | In Hospital Mortality |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | In Hospital Mortality |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Portable Hemodynamic Monitoring on Hosp Units | Wake Forest University Health Sciences | 336.716.4498 | akhanna@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2021 | Apr 26, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2021 | Nov 22, 2021 | ICF_000.pdf |
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The 2 wards will alternate every 4 weeks as to blinded/unblinded allocations. Blinded will be continuous ward monitoring with alarms silenced and screens covered; unblinded will be continuous monitoring accessible to clinicians with pre-specified alerts at MAP <65 mmHg, heart rate >110 b/m, and SpO2 <90%. Of note, to ensure patient safety and no risk in either arm, factory alarm limits (see table under human subjects protection) at extremes of physiological vital signs will stay on in the blinded/silenced arm, and both arms will have every 4 hourly checks by nursing teams.
| Patient Satisfaction Survey |
Score ranges from 5-50 with higher score denoting better outcome. |
| Ward discharge on 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
| ViSi Monitor Nursing Staff Survey | Survey showing the nursing perceptions of Certification for Neurophysiological Intraoperative Monitoring (CNIM) as well as the value of these devices in the care of their patients. Survey will obtain impressions of device from nurses. And descriptive statistics will be obtained regarding nurse's impressions of this technology after its having been implemented. Data will be reported via percentages the responses received. | After discharge over a period of 7 days |
| BG001 | Unblinded Ward | Continuous ward monitoring with hallway monitor screens accessible for viewing but with alarm limits more narrow. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will be able to view the hallway monitors showing the vital signs in all of the rooms and/or log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered. Continuous monitoring accessible to clinicians with pre-specified alerts at Mean Arterial Pressure (MAP) <65 mmHg, heart rate >110 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <90%. Every 4 hourly checks by nursing teams unless otherwise ordered. ViSi device: Mobile patient monitoring system for vital signs. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Unblinded Ward | Continuous ward monitoring with hallway monitor screens accessible for viewing but with alarm limits more narrow. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will be able to view the hallway monitors showing the vital signs in all of the rooms and/or log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered. Continuous monitoring accessible to clinicians with pre-specified alerts at Mean Arterial Pressure (MAP) <65 mmHg, heart rate >110 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <90%. Every 4 hourly checks by nursing teams unless otherwise ordered. ViSi device: Mobile patient monitoring system for vital signs. |
|
|
| Primary | Duration of Tachycardia in Minutes | Tachycardia defined as >110 beats/min. | Posted | Median | Inter-Quartile Range | Minutes | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
|
|
|
| Primary | Duration of Hypoxemia (SpO2 < 90%) in Minutes | Duration of Hypoxemia defined as SpO2 < 90% in Minutes | Posted | Median | Inter-Quartile Range | Minutes | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
|
|
|
| Secondary | Clinical Nursing Intervention Responses Scale | Clinical nursing intervention responses over the duration of the trial will be categorized as (1) none, (2) independent nursing intervention, (3) notification of physician team, or (4) activation of the hospital Emergency or Rapid Response System. Scale ranges from 1-4 with 4 denoting a worse outcome. | nurses did not enter timely responses in the EMR and therefore there is no data for that outcome measure. | Posted | Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
|
|
| Other Pre-specified | Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS) | Determined by blood troponin levels. Concentrations ≥0.03 ng/ml will be considered MINS if there is no evidence of a non-ischemic etiology. | Posted | Count of Participants | Participants | Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
|
|
|
| Other Pre-specified | Patient Satisfaction Survey | Score ranges from 5-50 with higher score denoting better outcome. | OM Data not collected | Posted | Ward discharge on 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) |
|
|
| Other Pre-specified | ViSi Monitor Nursing Staff Survey | Survey showing the nursing perceptions of Certification for Neurophysiological Intraoperative Monitoring (CNIM) as well as the value of these devices in the care of their patients. Survey will obtain impressions of device from nurses. And descriptive statistics will be obtained regarding nurse's impressions of this technology after its having been implemented. Data will be reported via percentages the responses received. | OM Data not collected | Posted | After discharge over a period of 7 days |
|
|
| 7 |
| 431 |
| 7 |
| 431 |
| 0 |
| 431 |
| EG001 | Unblinded Ward | Continuous ward monitoring with hallway monitor screens accessible for viewing but with alarm limits more narrow. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will be able to view the hallway monitors showing the vital signs in all of the rooms and/or log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered. Continuous monitoring accessible to clinicians with pre-specified alerts at Mean Arterial Pressure (MAP) <65 mmHg, heart rate >110 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <90%. Every 4 hourly checks by nursing teams unless otherwise ordered. ViSi device: Mobile patient monitoring system for vital signs. | 4 | 448 | 4 | 448 | 0 | 448 |
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