A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Blinded Ward 1 Continuous ward monitoring with hallway monitor screens covered. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered. |
Device: ViSi device
Mobile patient monitoring system for vital signs.
|
| Experimental: Unblinded Ward 2 Continuous ward monitoring with hallway monitor screens accessible for viewing but with alarm limits more narrow. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will be able to view the hallway monitors showing the vital signs in all of the rooms and/or log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered. |
Device: ViSi device
Mobile patient monitoring system for vital signs.
|
| Active Comparator: Blinded Ward 2 Continuous monitoring accessible to clinicians with pre-specified alerts at Systolic Blood Pressure alert <70, no Mean Arterial Pressure alert, heart rate >150 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <80%. Every 4 hourly checks by nursing teams unless otherwise ordered. These alarms are consistent with current standard of care. |
Device: ViSi device
Mobile patient monitoring system for vital signs.
|
| Experimental: Unblinded Ward 1 Continuous monitoring accessible to clinicians with pre-specified alerts at Mean Arterial Pressure (MAP) <65 mmHg, heart rate >110 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) <90%. Every 4 hourly checks by nursing teams unless otherwise ordered. |
Device: ViSi device
Mobile patient monitoring system for vital signs.
|
Outcome Measures
Primary Outcome Measures
- Duration of Hypotension in Minutes [Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)]
Hypotension defined as MAP <65 mmHg.
- Duration of Tachycardia in Minutes [Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)]
Tachycardia defined as >110 beats/min.
- Duration of Hypoxemia in Minutes [Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)]
Hypoxemia defined as SpO2<90%.
Secondary Outcome Measures
- Clinical Nursing Intervention Responses Scale [Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)]
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.
Other Outcome Measures
- Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS) [Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)]
Determined by blood troponin levels. Concentrations ≥0.03 ng/ml will be considered MINS if there is no evidence of a non-ischemic etiology.
- Patient Satisfaction Survey [Ward discharge on 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)]
Score ranges from 5-50 with higher score denoting better outcome.
- ViSi Monitor Nursing Staff Survey [After discharge over a period of 7 days]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Univesity Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Ashish Khanna, M.D., Wake Forest University Health Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00063530