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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574908
• Other study ID #: IRB00063530
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: October 8, 2021

Study information

• Verified date: October 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 879
• Est. completion date: October 8, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Respiratory Complications of Care

Intervention

Device:
• ViSi device
Mobile patient monitoring system for vital signs.

Locations

Country	Name	City	State
United States	Wake Forest Univesity Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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
Primary	Duration of Hypotension in Minutes	Hypotension defined as MAP <65 mmHg.	Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Primary	Duration of Tachycardia in Minutes	Tachycardia defined as >110 beats/min.	Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Primary	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	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)