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

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 Overview

• Status: Recruiting
• Conditions: Airway Extubation
• Intervention / Treatment: Device: Extubation Advisor

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Andrew JE Seely, MD, PhD, FRCSC; Phone Number: 74052 613-737-8899; Email: aseely@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital, General Campus
      • Contact: Andrew Seely, MD; Phone Number: 75052 613-737-8899; Email: aseely@ottawahospital.on.ca
      • Principal Investigator: Andrew JE Seely, MD PhD FRCSC
      • Principal Investigator: Karen Burns, MD FRCPC MSc
      • Sub-Investigator: Jamie Brehaut, PhD
      • Sub-Investigator: Christophe Herry, PhD
      • Sub-Investigator: Bram Rochwerg, MD MSc FRCPC
      • Sub-Investigator: Aimee Sarti, MD FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Arm; 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.

Device: Extubation Advisor; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Upon study completion, 4 months after study initiation
Evaluate feasibility of entering greater than 90% of participant clinical data into the Extubation Advisor tool	Feasibility of participant clinical data entry will be evaluated by determining if greater than 90% of the time, participant clinical data is fully entered 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	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	Upon study completion, 4 months after study initiation
Evaluate opinions of Physicians and Respiratory Therapists regarding Extubation Advisor	Usability, perceived value, identified behaviours, perceived barriers and drivers, and perceived impact will be assessed through interviews with respiratory therapists and attending physicians	Upon study completion, 4 months after study initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate feasibility of completing greater than 90% of clinical CRFs	Feasibility of completing the clinical case report forms will be evaluated by determining if greater than 90% of the time, clinical CRFs are complete	Upon study completion, 4 months after study initiation

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Andrew JE Seely, MD, PhD, FRCSC, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No