N/A
N=879
A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards
Hemodynamic Instability · Respiratory Complications of Care
Bottom Line
View on ClinicalTrials.gov: NCT04574908 ↗Enrolled (actual)
879
Serious AEs
1.3%
Results posted
Nov 2022
Primary outcome: Primary: Duration of Hypotension in Minutes — 0.00; 0.00 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ViSi device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Hypotension in Minutes |
0.00; 0.00 | — |
| PRIMARY Duration of Tachycardia in Minutes |
0.01; 0.01 | — |
| PRIMARY Duration of Hypoxemia (SpO2 < 90%) in Minutes |
0.04; 0.03 | — |
| SECONDARY Clinical Nursing Intervention Responses Scale |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04574908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.