Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support
ConditionAirway Extubation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Critically ill adults (age≥18)
Invasive ventilation for >48 hours
Who are expected to undergo an initial SBT within the next 48 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)
Disqualifiers
Suffer from known or suspected peripheral severe myopathy or neuropathy, or limb weakness or paralysis or central (e.g., post arrest, large intracranial stroke or bleed) injury or Glasgow Coma Scale (GCS) < 6
Do not wish to be re-intubated as part of their treatment goals
Were previously extubated during the same ICU admission
Have undergone 1 or more SBTs where the SBT was clearly documented in the chart and/or the PS was reduced to the SBT level of 8 or less during the 24 hour period prior to randomization
Trial design
Design model
Parallel
Treatments tested in this trial
Extubation Advisor
DeviceParticipants 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. The clinical outcome case report form will be completed at the time of hospital discharge.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Extubation AdvisorExperimental treatment 1 intervention
Group B: Standard of Care ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Evaluate the feasibility of enrolling 1-2 patients per centre per month
Feasibility of patient enrolment will be evaluated by determining if 1-2 patients are enrolled per centre per month.
Time frame
Upon study completion, 12 months after study initiationSecondary outcomes
1
Evaluate feasibility of consenting greater than 75% of eligible patients
Feasibility of consenting eligible patients will be evaluated by determining if greater than 75% of eligible patients are consented to participate.
Time frame
Upon study completion, 12 months after study initiation2
Evaluate feasibility of randomizing greater the 95% of consented patients
Feasibility of randomizing consented patients will be evaluated by determining if greater than 95% of consented patients are randomized to either the intervention or standard of care arm.
Time frame
Upon study completion, 12 months after study initiation3
Evaluate feasibility of generating and delivering greater than 80% of EA reports to the attending physician
Feasibility of EA report generation will be evaluated by determining if greater than 80% of the time, EA reports are generated and delivered to the attending physician.
Time frame
Upon study completion, 12 months after study initiation4
Evaluate feasibility of crossovers between the intervention and control arms occurring less than 10% of the time
Feasibility of limiting crossovers will be evaluated by determining if crossovers between the intervention and control arms occur less than 10% of the time.
Time frame
Upon study completion, 12 months after study initiationSponsors and contacts
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Source ClinicalTrials.gov