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

Respiratory Insufficiency Clinical Trial

— IPI  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050983
• Other study ID #: COVMOPO0525
• Status: Completed
• Start date: February 15, 2017
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2020
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: September 10, 2020
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Depression
• Respiratory Insufficiency

Intervention

Device:
• IPI
Enable the IPI algorithm and IPI alarm algorithm

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Utility of IPI and IPI Alarm	Adjusted Hospital Length of Stay in both Phases	Not to exceed nine months of observation
Secondary	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