Respiratory DepressionIPINCT03050983
Determination of the Clinical Impact of Continuous Surveillance Monitoring (SM) and Utility of IPI.
An observational study of Respiratory Depression and Respiratory Insufficiency, run by Medtronic - MITG at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Depression, Respiratory Insufficiency
- What is being tested?
- IPI
- Type of treatment
- Medical device
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 10 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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).
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.
Read the 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.
- Conditions
- Respiratory Depression, Respiratory Insufficiency
- Being tested
- IPI
- Keywords
- Respiratory Compromise
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPIDevice
Also called Integrated Pulmonary Index (IPI)
Enable the IPI algorithm and IPI alarm algorithm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Utility of IPI and IPI Alarm
Adjusted Hospital Length of Stay in both Phases
Measured: Not to exceed nine months of observation
Secondary outcomes (1)
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.
Measured: Not to exceed 24 months of reported escalation of care events to the Principal Investigator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start15 Feb 2017
- Primary completion26 Jan 2018
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liza Weavind, MBBCh,FCCM,MMHC, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050983
- Sponsor's protocol ID
- COVMOPO0525
- Acronym
- IPI
- Status last verified
- Sep 2020
- First submitted
- 9 Feb 2017
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03050983
- Acronym / sponsor ID
- IPI / COVMOPO0525
- Conditions
- Respiratory Depression, Respiratory Insufficiency
- Keywords
- Respiratory Compromise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: IPIEnable 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPIAlso: Integrated Pulmonary Index (IPI)Enable the IPI algorithm and IPI alarm algorithm | Device | Phase II |
Primary outcome
Clinical Utility of IPI and IPI Alarm
Time frame: Not to exceed nine months of observation
Adjusted Hospital Length of Stay in both Phases
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No. No plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liza Weavind, MBBCh,FCCM,MMHC principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Depression and Respiratory Insufficiency, run by Medtronic - MITG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Utility of IPI and IPI Alarm (time frame: Not to exceed nine months of observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.