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

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

Sponsors

Lead Sponsor: Ottawa Hospital Research Institute

Source 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.

Overall Status Not yet recruiting
Start Date March 2021
Completion Date June 2021
Primary Completion Date May 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Evaluate feasibility of enrolling and consenting greater than 50% of eligible patients Upon study completion, 4 months after study initiation
Evaluate feasibility of capturing greater than 75% of wave form data Upon study completion, 4 months after study initiation
Evaluate feasibility of entering greater than 90% of participant clinical data into the Extubation Advisor tool 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 Upon study completion, 4 months after study initiation
Evaluate opinions of Physicians and Respiratory Therapists regarding Extubation Advisor Upon study completion, 4 months after study initiation
Secondary Outcome
Measure Time Frame
Evaluate feasibility of completing greater than 90% of clinical CRFs Upon study completion, 4 months after study initiation
Enrollment 72
Condition
Intervention

Intervention Type: Device

Intervention Name: Extubation Advisor

Description: 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.

Arm Group Label: Intervention Arm

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Andrew JE Seely, MD, PhD, FRCSC Principal Investigator The Ottawa Hospital
Overall Contact

Last Name: Andrew JE Seely, MD, PhD, FRCSC

Phone: 613-737-8899

Phone Ext.: 74052

Email: [email protected]

Location
Facility: The Ottawa Hospital, General Campus
Location Countries

Canada

Verification Date

January 2021

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Intervention Arm

Type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

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

Masking: None (Open Label)

Source: ClinicalTrials.gov