N/A
N=20
BP Management System User Acceptance Testing
Hypotension and Shock
Bottom Line
View on ClinicalTrials.gov: NCT04688450 ↗Enrolled (actual)
20
Serious AEs
45.0%
Results posted
Jan 2025
Primary outcome: Primary: Quantitative Nurse-subject Survey Response — 13; 4; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VIGORIS Blood Pressure Management Clinical Decision Support System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Andrew Tomas Reisner
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Nurse-subject Survey Response |
13; 4; 1; 0; 2 | — |
| PRIMARY Software Operation (Based on Real-time Observation) |
18; 0; 2 | — |
| PRIMARY Data Completeness |
18; 0; 2 | — |
| PRIMARY Software Operation (Based on Review of Error Logs) |
18; 1; 1 | — |
| SECONDARY Percentage of Time That the BP Forecast is Operative (Outcome 2.1) |
89.3 | — |
| SECONDARY Accuracy of the MAP Forecast (Outcome 2.2) |
0.2 | — |
| SECONDARY Percentage of Time That the True Future 20 Min Median MAP Falls Within the Forecast Cone (Outcome 2.3) |
99.4 | — |
| SECONDARY SHE Incidence (Outcome 3.1) |
4.2 | — |
| SECONDARY Percentage of Total SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.1) |
69.2 | — |
| SECONDARY Advance Warning Times (AWTs) for SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.2) |
6.8 | — |
| SECONDARY Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.3) |
69.2 | — |
| SECONDARY AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.4) |
6.8 | — |
| SECONDARY Percentage of Total SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.1) |
30.8 | — |
| SECONDARY AWTs for SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.2) |
-2.9 | — |
| SECONDARY Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.3) |
30.8 | — |
| SECONDARY AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.4) |
-3.8 | — |
| SECONDARY Percentage of Total SHEs Detected by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.1) |
0.0 | — |
| SECONDARY AWTs for SHEs Predicted by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.2) |
NA | — |
| SECONDARY Percentage of Total SHEs Detected by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.3) |
0.0 | — |
| SECONDARY AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.4) |
NA | — |
| SECONDARY Percentage of Total SHEs With False Resolutions (Outcome 3.5.1) |
100.0 | — |
| SECONDARY Percentage of Total SHE False Resolutions Detected by {Index > 35%} (Outcome 3.5.2) |
96.3 | — |
| SECONDARY Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} With InOp State During False Resolution (Outcome 3.5.3) |
0.3 | — |
| SECONDARY Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} Without InOp State During False Resolution (Outcome 3.5.4) |
3.4 | — |
| SECONDARY Percentage of Total SHE False Resolutions Detected by {Index > User's Index Threshold Setting} (Outcome 3.5.5) |
95.2 | — |
| SECONDARY Percentage of Total SHE False Resolutions Not Detected by {Index > User's Index Threshold Setting} With InOp State During False Resolution (Outcome 3.5.6) |
0.3 | — |
| SECONDARY Percentage of Total SHE False Resolutions Not Detected by {Index > User's Index Threshold Setting} Without InOp State During False Resolution (Outcome 3.5.7) |
4.5 | — |
| SECONDARY Incidence of Notification Events {Index > 35%} That Are Contiguous With SHEs (Outcome 3.6.1) |
2.3 | — |
| SECONDARY Incidence of Notification Events {Index > User's Index Threshold Setting} That Are Contiguous With SHEs (Outcome 3.6.2) |
2.3 | — |
| SECONDARY Incidence of Notification Events {Index > 35%} That Are Sentinel Notifications (Outcome 3.6.3) |
7.8 | — |
| SECONDARY Incidence of Notification Events {Index > User's Index Threshold Setting} That Are Sentinel Notifications (Outcome 3.6.4) |
7.1 | — |
| SECONDARY Incidence of Notification Events {Index > 35%} That Are False Notifications (Outcome 3.6.5) |
10.0 | — |
| SECONDARY Incidence of Notification Events {Index > User's Index Threshold Setting} That Are False Notifications (Outcome 3.6.6) |
10.7 | — |
| SECONDARY Incidence of Notification Events {Index > 35%} Contiguous With an SHE False Resolution (Outcome 3.6.7) |
3.2 | — |
| SECONDARY Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE False Resolution (Outcome 3.6.8) |
3.6 | — |
| SECONDARY Incidence of Notification Events {Index > 35%} Contiguous With an SHE True Resolution, Overall (Outcome 3.6.9) |
3.6 | — |
| SECONDARY Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE True Resolution, Overall (Outcome 3.6.10) |
3.6 | — |
| SECONDARY Incidence of Notification Events {Index > 35%} Contiguous With an SHE True Resolution, Suppressible (Outcome 3.6.11) |
0.7 | — |
| SECONDARY Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE True Resolution, Suppressible (Outcome 3.6.12) |
0.7 | — |
| SECONDARY Incidence of Notification Events {Index > 35%} With Onset During an SHE (Outcome 3.6.13) |
1.3 | — |
| SECONDARY Incidence of Notification Events {Index > User's Index Threshold Setting} With Onset During an SHE (Outcome 3.6.14) |
1.3 | — |
| SECONDARY Duration of False Notification Events {Index > 35%} (Outcome 3.6.15) |
3.8 | — |
| SECONDARY Duration of False Notification Events {Index > User's Index Threshold Setting} (Outcome 3.6.16) |
3.8 | — |
| SECONDARY Stuttering Hypotension Incidence (Outcome 3.7.1) |
3.2 | — |
| SECONDARY Percentage of Total Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.2) |
40.0 | — |
| SECONDARY AWTs for Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.3) |
1.3 | — |
| SECONDARY Percentage of Total Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.4) |
40.0 | — |
| SECONDARY AWTs for Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.5) |
1.3 | — |
| SECONDARY Percentage of Total Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.6) |
60.0 | — |
| SECONDARY AWTs for Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.7) |
-8.0 | — |
| SECONDARY Percentage of Total Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.8) |
60.0 | — |
| SECONDARY AWTs for Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.9) |
-8.0 | — |
| SECONDARY Percentage of Total Stuttering Hypotension Episodes Not Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.10) |
0.0 | — |
| SECONDARY Percentage of Total Stuttering Hypotension Episodes Not Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.11) |
0.0 | — |
Summary
This is a feasibility study for an investigational clinical decision support system ("the System") intended to optimize the management of blood pressure (BP) for patients during vasopressor infusion. The investigational outcomes are the perceptions of the nurse-subjects who are managing the BP of the patient-subjects; the operational performance of the System; and any technical failures of the software during real-time operation.
Eligibility Criteria
Inclusion Criteria
- Adult patient (18 years or older) receiving continuous vasopressor infusion to maintain blood pressure;
- Clinician treating patient estimates future duration of vasopressor infusion likely at least 4 additional hours;
- Provider order has been made that sets lower limit for mean arterial pressure;
- Indwelling arterial catheter has been placed for continuous blood pressure monitoring.
Exclusion Criteria
- Lack of consent or at the discretion of the patient's primary nurse;
- The discretion of any of the patient's other clinical providers;
- People who do not speak English will be excluded. The rationale is that this protocol involves the bedside deployment of an investigational system plus longitudinal observation. Our mitigation for psychosocial risk involves a continual observer who can monitor for any evidence of subject psychosocial discomfort, which involves the ability to effectively communicate with the subject throughout the duration of the protocol. This therefore excludes patients who do not speak English.
- Patients who are on two simultaneous vasopressors running at maximum doses (per the ICUs own protocols) or who is on one maximum-dose vasopressor and has a contraindication to receiving a second vasopressor (e.g., insufficient vascular access).
- Patients who are hypoxic (SpO2 < 90%) despite maximum inspired oxygen (100% for patients receiving mechanical ventilation, or 10L high-flow in patients who are not candidates for mechanical ventilation).
- Provider order has been made that sets lower limit for SBP (because our system does not have the capability to provide decision-support for an SBP lower limit).
- Enhanced respiratory precautions for COVID.
Data sourced from ClinicalTrials.gov (NCT04688450). 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.