N/A
Completed N=879
A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards
Hemodynamic Instability · Respiratory Complications of Care
Source: ClinicalTrials.gov NCT04574908 ↗
Enrolled (actual)
879
Serious AEs
1.3%
Results posted
Nov 2022
Primary outcomePrimary: Duration of Hypotension in Minutes — 0.00; 0.00 Minutes
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.
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 |
— | — |
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. Informational only — not medical advice.