Extubation Advisor for Extubation

(LEADS Trial)

Recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the process of removing breathing tubes from critically ill patients in the ICU by using a tool called the Extubation Advisor. The tool combines doctor assessments with predictive data to help make safer, more effective decisions about when to remove a patient's ventilator. Patients who have been invasively ventilated for over 48 hours and are preparing for a breathing test to determine if they can breathe independently might be suitable for this trial. The trial will compare the new tool's effectiveness against current standard care practices. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance patient care in the ICU.

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 prior data suggests that the Extubation Advisor is safe for use in extubation decision-making?

Research shows that the Extubation Advisor (EA) tool is safe for people. In an earlier study, the EA tool assisted doctors and respiratory therapists in deciding when to remove breathing tubes. The study found that medical staff accepted the tool and it did not harm patients. This indicates the tool can be safely used alongside regular hospital care. Additionally, since this trial is in a "Not Applicable" phase, it primarily assesses the practicality of using the tool rather than testing new drugs or treatments, resulting in less risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Extubation Advisor because it offers a new way to support clinical decisions during extubation, which is when a patient is taken off mechanical ventilation. Unlike traditional methods that rely mostly on a clinician's judgment and standard spontaneous breathing trials (SBT), the Extubation Advisor analyzes wave form data from these trials to provide an additional layer of insight. This could potentially make extubation decisions more precise and safer, reducing the risk of complications. The hope is that this technology will enhance patient outcomes by offering tailored guidance that goes beyond what standard care currently provides.

What evidence suggests that the Extubation Advisor is effective for extubation decision-making?

Research shows that the Extubation Advisor (EA) tool, which participants in this trial may receive, helps doctors decide when a patient is ready to come off a ventilator. In a previous study, the EA tool, which examines a patient's breathing, predicted successful removal of the breathing tube better than current methods. This tool uses information from breathing tests to create a report that assists doctors in making this decision. Additionally, early results suggest that both respiratory therapists and doctors find the tool easy to use, making it practical for hospitals. The goal is to improve outcomes for patients who need help with breathing machines. ^{1 4 5 6 7}

Who Is on the Research Team?

Karen Burns, MD PhD FRCSC

Principal Investigator

Unity Health Toronto - St. Michael's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11927467/

Liberation from mechanical ventilation using Extubation ...

The EA tool estimates an individual patients' risk for extubation failure based on (1) the individual patient's respiratory rate variability ( ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05506904

Liberation From Mechanical Ventilation Using Extubation ...

Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides ...

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2815445

Spontaneous Breathing Trial Techniques for Extubating ...

Limited data showed that patients who underwent ATC and CPAP compared with PS SBTs had a significantly higher successful extubation rate.

4.

obsmedical.com

obsmedical.com/extubation-advisor-ea/

Extubation Advisor (EA)

Extubation Advisor (EA) is the first clinical decision support tool developed to provide prediction of extubation outcomes and standardize the assessment of ...

5.

bmjopen.bmj.com

bmjopen.bmj.com/content/11/8/e045674

Feasibility of implementing Extubation Advisor, a clinical ...

In this study, we evaluated the feasibility and clinical impressions of Extubation Advisor (EA), a comprehensive clinical extubation decision support (CDS) ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02988167

Introducing and Evaluating Extubation Advisor (EA)

This study is a mixed methods, pilot phase I observational study of the clinical implementation of a novel clinical decision support product, Extubation Advisor ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38393729/

Spontaneous Breathing Trial Techniques for Extubating ...

Main outcomes and measures: Primary outcomes included SBT success, extubation success, and reintubation. Results: The systematic review and ...