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Decision Support Tool
Extubation Advisor for Extubation (LEADS Trial)
Phase 1
Waitlist Available
Led By Karen Burns, MD, PhD, FRCSC
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon study completion, 12 months after study initiation
Awards & highlights
LEADS Trial Summary
This trial will assess the feasibility of using a bedside decision support tool to help ICU clinicians with extubation decision-making.
LEADS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon study completion, 12 months after study initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon study completion, 12 months after study initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the feasibility of enrolling 1-2 patients per centre per month
Secondary outcome measures
Evaluate feasibility of collecting complete patient outcomes greater than 90% of the time
Evaluate feasibility of consenting greater than 75% of eligible patients
Evaluate feasibility of crossovers between the intervention and control arms occurring less than 10% of the time
+6 moreLEADS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Extubation AdvisorExperimental Treatment1 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 ArmActive Control1 Intervention
Participants will undergo SBTs as directed by clinicians. The EA device will not be used.
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,591 Total Patients Enrolled
2 Trials studying Extubation
720 Patients Enrolled for Extubation
Karen Burns, MD, PhD, FRCSCPrincipal InvestigatorUnity Health Toronto - St. Michael's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You already have a surgically-created hole in your neck called a tracheostomy.You do not want to be put on a breathing machine again as part of your treatment plan.You are expected to require a breathing machine for more than 48 hours before a breathing test.You have severe weakness or paralysis in your limbs or a recent serious brain injury.You can participate in the study whether or not you have COVID-19.You are very sick and expected to pass away soon.The study is not open to adults (18 years or older) who are seriously ill.
Research Study Groups:
This trial has the following groups:- Group 1: Extubation Advisor
- Group 2: Standard of Care Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the Extubation Advisor app sanctioned by the FDA?
"Given that Extubation Advisor is still in phase 1, there is limited evidence to support its safety and efficacy. For this reason, our team at Power gave it a score of 1 out of 3."
Answered by AI
Is there still capacity for participants in this trial?
"It appears that this clinical trial is not presently recruiting participants, as per the data available on clinicaltrials.gov. This study was initially posted on November 1st 2022 and last edited August 16th 2022. There are still 4 other trials searching for patients to enroll at this time."
Answered by AI
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