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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Respiratory Depression
• Intervention / Treatment: Device: IPI

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.

• Study Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The target study population will be adult patients on the general care floors (GCF) units where the dual parameter CS20p monitor is installed and used according to the Vanderbilt University Medical Center (VUMC) standard of care. Only those patients monitored via the CS20p with both capnography and pulse oximetry (dual parameters) for standard of care may be enrolled for observation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase I; Prospective observation of alarmed events on the general care floor with continuous capnography and pulse oximetry monitoring prior to enabling IPI.
Phase II; 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.	Device: IPI; Enable the IPI algorithm and IPI alarm algorithm; Other Names: Integrated Pulmonary Index (IPI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Utility of IPI and IPI Alarm	Adjusted Hospital Length of Stay in both Phases	Not to exceed nine months of observation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Not to exceed 24 months of reported escalation of care events to the Principal Investigator

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Liza Weavind, MBBCh,FCCM,MMHC, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2017
• Primary Completion (ACTUAL): January 26, 2018
• Study Completion (ACTUAL): September 10, 2020

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (ACTUAL): February 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Respiratory Compromise
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: COVMOPO0525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes