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

Medtronic - MITG440 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

440

Conditions

Respiratory Depression Respiratory Insufficiency

Interventions

IPIDEVICE

Enable the IPI algorithm and IPI alarm algorithm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Clinical Utility of IPI and IPI Alarm

Adjusted Hospital Length of Stay in both Phases

Time frame: Not to exceed nine months of observation

Secondary Outcomes

Clinical Impact of continuous surveillance capnography and pulse oximetry monitoring

Number of alarms per patient, number of rapid response team activation, number of intensive care unit escalation and hospital cost per patient in each Phase.

Time frame: Not to exceed 24 months of reported escalation of care events to the Principal Investigator

Data from ClinicalTrials.gov

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