Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 1:15 PM
Study NCT ID:
NCT02988167
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Introducing and Evaluating Extubation Advisor
Sponsor:
Ottawa Hospital Research Institute
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EA
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: