Extubation Advisor for Extubation

(LEADS Trial)

Recruiting at 11 trial locations

Overseen By Karen Burns, MD MSc FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Severe myopathy, Neuropathy, Moribund, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Timely and safe extubation in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation are associated with increased morbidity, mortality, costs, intensive care unit (ICU) stays, and a risk for aerosolization of COVID-19 to health care providers. A Spontaneous Breathing Trial (SBT) is the current standard of care to assess a patient's readiness for extubation. However, SBTs are performed in various ways and have poor ability to predict successful extubation on their own. There is an urgent need to improve and standardize extubation decision-making. In a prior multicenter study, the investigators showed that decreased respiratory rate variability during SBTs predicted extubation failure better than other predictive indices. The Extubation Advisor (EA) tool combines clinician's assessments of extubation readiness with predictive analytics and risk mitigation strategies for individual patients. In a single centre observational study, the investigators demonstrated the ability to deliver EA reports to the bedside and acceptability of this decision-support tool to respiratory therapists (RTs) and physicians (MDs). The investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes. They will include critically ill adults who are invasively ventilated for \>48 hours and are ready to undergo an SBT. Patients in the intervention arm undergo an EA assessment and treating clinicians (RTs, MDs) will receive an EA report for each SBT conducted. The EA report will help to guide extubation decision-making. Patients in the control arm receive standard care. SBTs will be directed by clinicians. The primary feasibility outcome will reflect the ability to recruit the desired population. The investigators will also assess the usefulness of the tool to MDs and complete an analysis of resource utilization to inform future economic analyses of cost-effectiveness. The investigators aim to recruit 1 to 2 patients/month/center. The LEADS trial is novel and low-risk. It is the first trial to evaluate use of a bedside decision support tool to assist ICU clinicians with extubation decision-making. The LEADS pilot trial will inform the design of a future, large-scale randomized controlled trial that is expected to enhance the care delivered to critically ill patients, improve extubation outcomes, and inform extubation practice in ICUs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Extubation Advisor?

The Extubation Advisor (EA) is a tool designed to help make better decisions about when to remove a breathing tube. Research shows that using similar tools, like an extubation checklist, can improve how often healthcare providers follow best practices and reduce the chances of needing to put the tube back in. ^{1 2 3 4 5}

How is the Extubation Advisor treatment different from other extubation treatments?

The Extubation Advisor is unique because it is a clinical decision support tool designed to improve decision-making for extubation in the ICU, unlike standard spontaneous breathing trials that do not optimize prediction or standardize assessment. ^{1 2 3 6 7}

Research Team

Karen Burns, MD PhD FRCSC

Principal Investigator

Unity Health Toronto - St. Michael's Hospital

Eligibility Criteria

This trial is for critically ill adults in the ICU, ready for a breathing test to see if they can breathe without a machine. They must be on invasive ventilation for over 48 hours and can have COVID-19. People who've had previous breathing tests, tracheostomies, severe muscle or nerve issues, low coma scale scores, or are near death cannot join.

Inclusion Criteria

In the intensive care unit (ICU)

Ready to undergo an initial SBT within the next 24 hours with a view to extubation as per treating MDs. As per the FAST trial, an SBT will be defined as a focused assessment on low ventilator settings [T-piece, continuous positive airway pressure (CPAP), or PS < 8 cm H2O regardless of positive end-expiratory pressure (PEEP)]

Able to provide informed consent (through a surrogate)

Exclusion Criteria

Were previously extubated during the same ICU admission

Have undergone 1 or more SBTs

You already have a surgically-created hole in your neck called a tracheostomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm undergo an EA assessment and receive an EA report for each SBT conducted to guide extubation decision-making.

12 months

Control

Participants in the control arm receive standard care with SBTs directed by clinicians without EA assessments.

12 months

Follow-up

Participants are monitored for safety and effectiveness after extubation.

4 weeks

Treatment Details

Interventions

• Extubation Advisor

Trial Overview The LEADS Pilot Trial is testing an Extubation Advisor (EA) tool that helps doctors decide when patients can safely stop using ventilators. Some patients will get standard care while others will use the EA tool during their breathing tests to guide decisions.

Participant Groups

Group I: Extubation Advisor Experimental Treatment 1 Intervention

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 II: Standard of Care Arm Active Control 1 Intervention

Participants will undergo SBTs as directed by clinicians. The EA device will not be used.

Extubation Advisor is already approved in Canada for the following indications:

Approved in Canada as Extubation Advisor for:

• Assistance in extubation decision-making for critically ill patients

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Findings from Research

A 1% reduction in failed extubation in ICU patients could save hospitals approximately C$289 per patient, highlighting the potential economic benefits of improving extubation success rates.

To be cost-effective, the Extubation Advisor tool must achieve at least a 0.24% reduction in extubation failure rates, which could lead to significant annual savings for large hospitals with high intubation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic feasibility of a novel tool to assist extubation decision-making: an early health economic modeling. Zheng, K., Kumar, S., Sarti, AJ., et al.[2022]

The Extubation Advisor (EA) tool was evaluated in a study involving 117 patients and showed a low extubation failure rate of 11% in low-risk patients and 21% in high-risk patients, indicating its potential effectiveness in predicting extubation readiness.

Clinicians rated the EA tool positively for its usability, with 94% finding data entry acceptable, suggesting that it could enhance decision-making in extubation processes in intensive care units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of implementing Extubation Advisor, a clinical decision support tool to improve extubation decision-making in the ICU: a mixed-methods observational study. Sarti, AJ., Zheng, K., Herry, CL., et al.[2021]

A new extubation protocol was successfully implemented in a medical/surgical ICU, following educational sessions for the multidisciplinary team, highlighting the importance of early discontinuation of ventilator support.

Data from the first 47 patients extubated using this protocol showed that it was well-received by the ICU team and has become a standard part of ventilator management, although specific reintubation rates were not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an RN/RT-initiated extubation protocol. Hynes-Gay, P., Brindley, A., Chu, W., et al.[2019]

A predictive model for assessing the risk of reintubation after cardiac surgery showed strong discriminative ability across three academic medical centers, with a c-statistic of 0.77 in temporal validation and 0.73 in combined domain and geographic validation, indicating it can effectively identify patients at risk.

Despite its strong discrimination and low predictive error, the model exhibited low precision and recall, suggesting that further optimization is necessary before it can be reliably implemented in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External validation of a predictive model for reintubation after cardiac surgery: A retrospective, observational study. Freundlich, RE., Clifton, JC., Epstein, RH., et al.[2023]

The implementation of an evidence-based extubation checklist significantly improved documentation of patient readiness for extubation from 54% to 92.5% among 622 patients undergoing surgery.

Using the checklist also led to a reduction in preventable extubation failures, decreasing from 2.5 to 7.2 failures per month, demonstrating its effectiveness in enhancing patient safety during the postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an evidence-based extubation checklist to reduce extubation failure in patients with trauma: a pilot study. Howie, WO., Dutton, RP.[2012]

The All India Difficult Airway Association (AIDAA) emphasizes that extubation is as critical as intubation and requires careful planning, especially for patients with difficult airways or pre-existing conditions that may complicate the process.

AIDAA has developed an algorithm to guide extubation strategies, which includes assessing the patient's airway and planning for potential complications, such as airway collapse, to ensure a safe and effective extubation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All India Difficult Airway Association 2016 guidelines for the management of anticipated difficult extubation. Kundra, P., Garg, R., Patwa, A., et al.[2020]

In a study of 51 patients with difficult airways, using an airway exchange catheter (AEC) during extubation allowed for a high reintubation success rate of 92%, with 87% of those reintubated successfully on the first attempt.

The AEC strategy not only improved the chances of successful reintubation but also reduced complications during the process, highlighting its potential as a valuable tool in managing difficult airway situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous airway access for the difficult extubation: the efficacy of the airway exchange catheter. Mort, TC.[2007]

References

1. England pubmed.ncbi.nlm.nih.gov

Economic feasibility of a novel tool to assist extubation decision-making: an early health economic modeling. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of implementing Extubation Advisor, a clinical decision support tool to improve extubation decision-making in the ICU: a mixed-methods observational study. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Implementation of an RN/RT-initiated extubation protocol. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

External validation of a predictive model for reintubation after cardiac surgery: A retrospective, observational study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Implementation of an evidence-based extubation checklist to reduce extubation failure in patients with trauma: a pilot study. [2012]

6. India pubmed.ncbi.nlm.nih.gov

All India Difficult Airway Association 2016 guidelines for the management of anticipated difficult extubation. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Continuous airway access for the difficult extubation: the efficacy of the airway exchange catheter. [2007]