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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability; Respiratory Complications of Care
• Intervention / Treatment: Device: ViSi device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 879
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Univesity Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: ViSi device; Mobile patient monitoring system for vital signs.
Experimental: 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.	Device: ViSi device; Mobile patient monitoring system for vital signs.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	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)
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ashish Khanna, M.D., Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): October 6, 2021
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: postoperative care; postoperative monitoring; vital signs; portable monitor
• Other Study ID Numbers: IRB00063530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the IPD collected during the course of the study will be deidentified and then analyzed
• IPD Sharing Time Frame: immediately following publication. No end date available.
• IPD Sharing Access Criteria: any purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes