NCT04574908

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 879 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodynamic Instability
• Respiratory Complications of Care

Interventions

Type	Name	Description
DEVICE	ViSi device	Mobile patient monitoring system for vital signs.

Timeline

• Start date: 2020-10-07
• Primary completion: 2021-10-06
• Completion: 2021-10-08
• First posted: 2020-10-05
• Last updated: 2024-05-21
• Results posted: 2022-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study