Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool

Phase 1

Completed

Conditions: Airway Extubation

Interventions: Device: Extubation Advisor

Registration Number: NCT04708509

Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

Inclusion Criteria

In the Intensive Care Unit (ICU)
Able to provide informed consent (through a surrogate)
Invasive mechanical ventilation for > 48 hours
Ready for spontaneous breathing test (SBT) for assessment for extubation
At least partial reversal of the condition precipitating mechanical ventilation
Stabilization of other organ systems
Toleration of pressure support ventilation less than or equal to 14 cm H2O, (oxygen saturation (SpO2) greater than or equal to 90% with fraction of inspired oxygen (FiO2) less than or equal to 40% and positive end-expiry pressure (PEEP) less than or equal to 10cm H2O)
Hemodynamic stability (low - phenylephrine less than 50 ug/min; norepinephrine less than 5 ug/min; dobutamine less than 5 ug/kg/min; milrinone less than 0.4 ug/kg/min - or no vasopressors)
Stable neurological status (no deterioration in Glasgow coma score during prior 24 hours and, if measured, intracranial pressure (ICP) less than 20 mmHg)
Intact airway reflexes (adequate cough with suctioning and a gag reflex)
Normal sinus rhythm at the time of the SBT (no pacemaker)

Exclusion Criteria

Order not to re-intubate should the patient fail extubation
Anticipated withdrawal of life support
Known or suspected severe weakness (myopathy, neuropathy, or quadriplegia)
Tracheostomy
Prior extubation during current ICU stay

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Extubation Advisor	Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.

Primary Outcome Measures

Name	Time	Method
Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients	Upon study completion, 4 months after study initiation	Feasibility of patient enrolment and consent will be evaluated by determining if greater than 50% of eligible patients are enrolled and consented
Evaluate Feasibility of Capturing Greater Than 75% of Wave Form Data	Upon study completion, 4 months after study initiation	Feasibility of wave form data capture will be evaluated by determining if greater than 75% of the time, wave form data is captured
Evaluate Feasibility of Generating and Delivering Greater Than 80% of Extubation Advisor Reports to the Attending Physician	Upon study completion, 4 months after study initiation	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