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OpenTrials
Completed

NCT Number: NCT03050983

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

IPI

Device

Enable the IPI algorithm and IPI alarm algorithm

Other names: Integrated Pulmonary Index (IPI)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study 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).

Acronym: IPI

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Feb 13, 2017
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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