Clinical trial NCT03050983: Determination of the Clinical Impact of Continuous Surveillance Monitoring (SM) and Utility of 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Depression
Respiratory Insufficiency
Keywords: Respiratory Compromise
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2017-02-13
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Utility of IPI and IPI Alarm
timeFrame: Not to exceed nine months of observation
Secondary outcomes:
measure: Clinical Impact of continuous surveillance capnography and pulse oximetry monitoring
timeFrame: Not to exceed 24 months of reported escalation of care events to the Principal Investigator
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Liza Weavind, MBBCh,FCCM,MMHC
role: PRINCIPAL_INVESTIGATOR
References: