Expeditious, safe extubation is vitally important in the care of Intensive Care Unit (ICU) patients, as prolonged mechanical ventilation harms patients and failed extubation (i.e. re-intubation within 48 hrs) is associated with increased morbidity, mortality and costs. The urgent need to improve extubation failure is further highlighted by current observations suggesting that COVID-19 patients are at increased risk of both early and late extubation failure. The investigators previously found that decreased respiratory rate variability (indicative of reduced adaptability and/or increased stress) during Spontaneous Breathing Trials (SBTs) predicted extubation failure and outperformed the best available predictive indices. Combining this predictive analytic with standardized extubation readiness checklists and risk mitigation strategies, the investigators created the Extubation Advisor (EA). The investigators recently completed a single-center phase I mixed methods observational study (n=117) wherein there was demonstrated technical feasibility (i.e. ability to generate 92% EA of reports) and clinician acceptance of the EA tool. In the current open-label, multi-center interventional phase I study, the investigators will assess the feasibility and initial perceptions of EA implementation in the intensive care unit by (1) evaluating the feasibility of patient enrolment, data collection, and EA report generation, and (2) performing a mixed-methods analysis of critical care physician and respiratory therapist perceptions of EA. Findings from this study will inform a future randomized controlled trial assessing EA outcomes compared to standard of care, with the intent of aiding bedside decision-making, enhancing care delivery, and improving outcomes in critically ill patients with and without COVID-19.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
31
Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed.
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients
Feasibility of patient enrolment and consent will be evaluated by determining if greater than 50% of eligible patients are enrolled and consented
Time frame: Upon study completion, 4 months after study initiation
Evaluate Feasibility of Capturing Greater Than 75% of Wave Form Data
Feasibility of wave form data capture will be evaluated by determining if greater than 75% of the time, wave form data is captured
Time frame: Upon study completion, 4 months after study initiation
Evaluate Feasibility of Generating and Delivering Greater Than 80% of Extubation Advisor Reports to the Attending Physician
Feasibility of Extubation Advisor report generation will be evaluated by determining if greater than 80% of the time, an extubation report is successfully generated and delivered to the attending physician
Time frame: Upon study completion, 4 months after study initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.