A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards

Conditions
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Hemodynamic Instability, Respiratory Complications of Care

Intervention / Treatment
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* Device: ViSi device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 65 years of age >/= 45 years of age with at least 1 cardiovascular risk (hypertension, diabetes) Requiring a general or regional anesthetic as part of their surgical procedure. Requiring (or anticipated to require) at least a 48 hour hospital stay after surgery. All subjects aged 18 and older who are patients receiving ViSi monitoring on the 2 nursing units involved. Exclusion Criteria: < 48 hour hospital stay Receiving local anesthetic for their surgical procedure troponins not ordered if <65 years of age without a single cardiovascular risk factor or <45 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blinded Ward<br>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. | Device: ViSi device<br>* Mobile patient monitoring system for vital signs.<br>|
| Experimental: Unblinded Ward<br>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. | Device: ViSi device<br>* Mobile patient monitoring system for vital signs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative care, postoperative monitoring, vital signs, portable monitor