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

NCT ID: NCT04708509

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2023-01-13

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.

Conditions

Airway Extubation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Extubation Advisor

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew JE Seely, MD, PhD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

Countries

Canada

References

Hryciw BN, Hudek N, Brehaut JC, Herry C, Scales N, Lee E, Sarti AJ, Burns KEA, Seely AJE. Extubation Advisor: Implementation and Evaluation of A Novel Extubation Clinical Decision Support Tool. J Intensive Care Med. 2025 Apr;40(4):418-426. doi: 10.1177/08850666241291524. Epub 2024 Oct 24.

Reference Type: DERIVED

PMID: 39444331 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2681

Identifier Type: -

Identifier Source: org_study_id