Clinical trial NCT04574908: A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards
Official title: A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Respiratory Complications of Care
Keywords: postoperative care
postoperative monitoring
vital signs
portable monitor
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 879
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Hypotension in Minutes
timeFrame: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
measure: Duration of Tachycardia in Minutes
timeFrame: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
measure: Duration of Hypoxemia (SpO2 < 90%) in Minutes
timeFrame: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Secondary outcomes:
measure: Clinical Nursing Intervention Responses Scale
timeFrame: Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Other outcomes:
measure: Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS)
timeFrame: Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
measure: Patient Satisfaction Survey
timeFrame: Ward discharge on 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
measure: ViSi Monitor Nursing Staff Survey
timeFrame: After discharge over a period of 7 days
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Univesity Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ashish Khanna, M.D.
role: PRINCIPAL_INVESTIGATOR
References: