Trials / Completed
CompletedNCT03050983
Determination of the Clinical Impact of Continuous Surveillance Monitoring (SM) and Utility of IPI.
Observational Investigation to Determine Clinical Impact of Continuous Surveillance Monitoring (SM) on General Care Floors With a Nested Study to Determine the Clinical Utility of IPI (Integrated Pulmonary Index).
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 440 (actual)
- Sponsor
- Medtronic - MITG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Single site prospective observational nested study of bedside CS20p monitor on the GCF impeded into a retrospective review of the frequency of escalation of care with intermittent vitals signs compared to continuous respiratory monitoring.
Detailed description
Single site observational study of alarms and workflow on the general care floor where continuous surveillance monitoring (SM) with capnography and pulse oximetry is the standard of care before and after the Integrated Pulmonary Index is enabled within the context of a historical review of frequency of escalation of care as a function of the frequency and method of monitoring respiratory status. Observation of alarms will be electronically recorded on a Clinical Observation Tool (COT or iPad) that will have a virtual view of the CS20p measurements and alarm alerts for 24 hours on several patients at the same time. Patients will only be enrolled for 24 hours of observation of alarm status with associated patient activity and clinical interventions. Observation data with IPI disabled prior to implementation of IPI/IPI alarms will be used to evaluate optimal alarm alert settings including an IPI alert when enabled. Observation will continue with IPI enabled and alarms adjusted to study clinical utility of IPI on the GCF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IPI | Enable the IPI algorithm and IPI alarm algorithm |
Timeline
- Start date
- 2017-02-15
- Primary completion
- 2018-01-26
- Completion
- 2020-09-10
- First posted
- 2017-02-13
- Last updated
- 2020-09-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03050983. Inclusion in this directory is not an endorsement.