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

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Respiratory Complications of Care
• Interventions: Device: ViSi device

• Registration Number: NCT04574908
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-10-05
• Study Start: 2020-10-07
• Status Verified: 2021-10
• Primary Completion: 2021-10-06
• Study Completion: 2021-10-08
• Results First Submitted: 2022-10-28
• Results First Submitted QC: 2022-10-28
• Results First Posted: 2022-11-22
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 879

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blinded Ward	ViSi device	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	ViSi device	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.

Primary Outcome Measures

Name	Time	Method
Duration of Hypoxemia (SpO2 < 90%) in Minutes	Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)	Duration of Hypoxemia defined as SpO2 \< 90% in Minutes
Duration of Tachycardia in Minutes	Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)	Tachycardia defined as \>110 beats/min.
Duration of Hypotension in Minutes	Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)	Hypotension defined as MAP \<65 mmHg.

Secondary Outcome Measures

Name	Time	Method
Clinical Nursing Intervention Responses Scale	Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)	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.

Trial Locations

Locations (1)

Wake Forest Univesity Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States