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Knowing when to liberate critically ill patients from mechanical ventilation (i.e. extubation) is of great importance as both prolonged ventilation and failed extubation are associated with increased morbidity, mortality & costs. The study objective is to improve the safety of extubation by harnessing hidden information contained in the patterns of variation of heart and respiratory rate measured over intervals-in-time.
As a standard of care for patients who are intubated in the ICU; to assess ability to be extubated, a Spontaneous Breathing Trial (SBT) is performed, where the level of ventilator support is reduced, and patient's response is observed to predict if they will tolerate extubation.
Spontaneous breathing trials (SBTs) are standard of care in assessing extubation readiness; however, there are no universally accepted guidelines regarding their precise performance and reporting.
Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness & stress are associated with a loss of variability, the investigators have demonstrated that maintaining a high level of heart rate (HRV) and respiratory rate variability (RRV) prior to and throughout the Spontaneous Breathing Trial (SBT) will predict successful extubation, and a reduction in heart rate (HRV) and respiratory rate variability (RRV) predicts extubation failure.
Research to date has already demonstrated the added prognostic value and the investigators have derived a predictive model based on continuous monitoring of respiratory rate variability (RRV). The investigators are now poised to evaluate Extubation Advisor (EA) software with the overall goal to transform monitoring and improve care.
This study is a mixed methods, pilot phase I observational study of the clinical implementation of a novel clinical decision support product, Extubation Advisor.TM In this study the investigators will evaluate the feedback of RTs as well as the feedback of MDs post-treatment (extubation) decision.
Questionnaires will be sent to Respiratory Therapists (RT's) and Medical Doctors (MD's) to solicit feedback on the electronic Spontaneous Breathing Trial (SBT) Case Report Form (CRF) and the Extubation Advisor TM (EA) report. All questionnaires will be answered based on a rating scale of 1-5 where 1 is unacceptable and 5 is excellent.
As this proposed study is observational and has no impact on patient care/outcomes, and to avoid bias associated with requiring consent, the investigators believe this study represents one of the limited circumstances under which waived consent may be permitted.
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| Measure | Description | Time Frame |
|---|---|---|
| Introduce Extubation Advisor TM (EA) | Introduce Extubation Advisor TM (EA) in an observational study in patients being evaluated for extubation, specifically by: (i) engaging RTs to ensure waveform (EKG, CO2) monitoring is in place during spontaneous Breathing Trials (SBTs) and enter clinical data and assessment into the EA data entry screens, (ii) providing RTs and MDs with the EA report at least 48 hours after extubation. | 1 year |
| Evaluate Respiratory Therapist (RTs) feedback on the Extubation Advisor TM (EA) | Evaluate: quality and completeness of data elements and process of data entry, integration with existing RT clinical practice and workflow, time to completion of data entry, 48 hours post extubation/treatment decision obtain RT feedback on quality and overall impression of the report. | 1 year |
| Evaluate Intensivist (MD) feedback on the Extubation Advisor TM (EA) Report | Evaluate quality and completeness of report, ease of integration into existing MD clinical practice and workflow, overall impression and potential impact on decision making. | 1 year |
| Evaluate technical feasibility of future real-time implementation of Extubation Advisor TM (EA) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are being considered for extubation in the ICU
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| Name | Affiliation | Role |
|---|---|---|
| Aimee Sarti | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34385234 | Derived | Sarti AJ, Zheng K, Herry CL, Sutherland S, Scales NB, Watpool I, Porteous R, Hickey M, Anstee C, Fazekas A, Ramsay T, Burns KE, Seely AJ; Canadian Critical Care Trials Group. Feasibility of implementing Extubation Advisor, a clinical decision support tool to improve extubation decision-making in the ICU: a mixed-methods observational study. BMJ Open. 2021 Aug 12;11(8):e045674. doi: 10.1136/bmjopen-2020-045674. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 9, 2022 | |
| Unrelease | Nov 23, 2022 | |
| Release | Mar 16, 2023 | |
| Reset | Dec 15, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 9, 2022 | Nov 23, 2022 | |||
| Mar 16, 2023 |
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| Dec 15, 2023 |