Determination of the Clinical Impact of Continuous Surveillance Monitoring (SM) and Utility of IPI.

Medtronic

Status: Completed

Conditions: Respiratory Insufficiency; Respiratory Depression

Treatments: Device: IPI

Study type: Observational

Funder types: Industry

Identifiers

NCT03050983

COVMOPO0525

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Spontaneous breathing adults ≥ 18 years of age, both male and female
2. On dual parameter CS20p monitoring with both capnography and pulse oximetry per Vanderbilt standard of care to monitor patients for respiratory compromise.
3. Expected minimum duration of 24 hours of continued capnography and pulse oximetry monitoring.

Exclusion criteria

1. Those patients who are expected to be discharged within six hours on the randomly selected observation floor.
2. Those patients not on the randomly selected floor for observation.
3. Those subjects randomly removed from the selected floor for observation pool in order to limit the number of subjects to be observed.
4. Those subjects in rooms with limited Wi-Fi signal quality as per VUMC IT.

Trial design

440 participants in 2 patient groups

Phase I

Description:

Prospective observation of alarmed events on the general care floor with continuous capnography and pulse oximetry monitoring prior to enabling IPI.

Phase II

Description:

Enable the Integrated Pulmonary Index (IPI) and IPI alarm for the prospective observation of alarmed events on the general care floor with continuous capnography and pulse oximetry monitoring.

Treatment:

Device: IPI