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

Wake Forest University (WFU)

Status: Completed

Conditions: Respiratory Complications of Care; Hemodynamic Instability

Treatments: Device: ViSi device

Study type: Interventional

Funder types: Other

Identifiers

NCT04574908

IRB00063530

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 879 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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879 participants in 2 patient groups

Blinded Ward

Active Comparator group

Description:

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.

Treatment:

Device: ViSi device

Unblinded Ward

Experimental group

Description:

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.

Treatment:

Device: ViSi device