Hemodynamic Instability Clinical Trial
Official title:
A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards
Verified date | October 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Univesity Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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) |
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