Intubation Clinical Trial
Official title:
Introducing and Evaluating Extubation AdvisorTM: A Pilot Phase I Observational Study of a Novel Clinical Decision Support Tool to Improve Extubation Decision-making in the Intensive Care Unit
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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