Clinical trial NCT04708509: Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool
Official title: Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Airway Extubation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, multi-center interventional Phase 1 study to implement and evaluate perceptions of Extubation Advisor in consenting patients in the intensive care unit.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients
timeFrame: Upon study completion, 4 months after study initiation
measure: Evaluate Feasibility of Capturing Greater Than 75% of Wave Form Data
timeFrame: Upon study completion, 4 months after study initiation
measure: Evaluate Feasibility of Generating and Delivering Greater Than 80% of Extubation Advisor Reports to the Attending Physician
timeFrame: Upon study completion, 4 months after study initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Andrew JE Seely, MD, PhD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: