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

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ClinicalTrials.gov Identifier: NCT04708509
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Airway Extubation Device: Extubation Advisor Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : February 2023

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.




Primary Outcome Measures :
  1. Evaluate feasibility of enrolling and consenting greater than 50% of eligible patients [ Time Frame: 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

  2. Evaluate feasibility of capturing greater than 75% of wave form data [ Time Frame: 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

  3. Evaluate feasibility of entering greater than 90% of participant clinical data into the Extubation Advisor tool [ Time Frame: Upon study completion, 4 months after study initiation ]
    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

  4. Evaluate feasibility of generating and delivering greater than 80% of Extubation Advisor reports to the attending physician [ Time Frame: 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

  5. Evaluate opinions of Physicians and Respiratory Therapists regarding Extubation Advisor [ Time Frame: Upon study completion, 4 months after study initiation ]
    Usability, perceived value, identified behaviours, perceived barriers and drivers, and perceived impact will be assessed through interviews with respiratory therapists and attending physicians


Secondary Outcome Measures :
  1. Evaluate feasibility of completing greater than 90% of clinical CRFs [ Time Frame: Upon study completion, 4 months after study initiation ]
    Feasibility of completing the clinical case report forms will be evaluated by determining if greater than 90% of the time, clinical CRFs are complete



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708509


Contacts
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Contact: Andrew JE Seely, MD, PhD, FRCSC 613-737-8899 ext 74052 aseely@toh.ca

Locations
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Canada, Ontario
The Ottawa Hospital, General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Andrew Seely, MD    613-737-8899 ext 75052    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         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Andrew JE Seely, MD, PhD, FRCSC The Ottawa Hospital
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04708509    
Other Study ID Numbers: 2681
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No