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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03050983
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : September 30, 2020
Information provided by (Responsible Party):
Medtronic - MITG

Brief 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.

Condition or disease Intervention/treatment
Respiratory Depression Respiratory Insufficiency 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.

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Study Type : Observational
Actual Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Prospective
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).
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : September 10, 2020

Resource links provided by the National Library of Medicine

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 Name: Integrated Pulmonary Index (IPI)

Primary Outcome Measures :
  1. Clinical Utility of IPI and IPI Alarm [ Time Frame: Not to exceed nine months of observation ]
    Adjusted Hospital Length of Stay in both Phases

Secondary Outcome Measures :
  1. Clinical Impact of continuous surveillance capnography and pulse oximetry monitoring [ Time Frame: Not to exceed 24 months of reported escalation of care events to the Principal Investigator ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03050983

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Medtronic - MITG
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Principal Investigator: Liza Weavind, MBBCh,FCCM,MMHC Vanderbilt University Medical Center
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Responsible Party: Medtronic - MITG Identifier: NCT03050983    
Other Study ID Numbers: COVMOPO0525
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share

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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
Keywords provided by Medtronic - MITG:
Respiratory Compromise
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases