Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support: The Multicentre (LEADS) Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 24
- 主要终点
- Evaluate the feasibility of enrolling 1-2 patients per centre per month
研究概览
简要总结
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.
详细描述
Background: Timely and safe extubation (i.e. endotracheal tube removal) in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation (i.e. re-intubation<48 hrs; 15% incidence) 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 the intensive care unit. In a prior multicenter study (n=721), 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 (n=117; 2 ICUs), 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).
Proposed Trial: The investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes including recruitment of critically ill patients with and without COVID-19 and protocol adherence.
Patients: The investigators will include critically ill adults who are invasively ventilated for >48 hours and who are ready to undergo an SBT with a view to extubation.
Intervention: Patients in the intervention arm will 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, rather than direct extubation decision-making by MDs.
Control: Patients in the control arm will receive standard care. SBTs will be directed by clinicians, using current best evidence. No EA assessments will be made, and no EA reports will be generated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statisticians will be blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •Already have a tracheostomy
- •Are moribund or expected to die.
研究组 & 干预措施
Extubation Advisor
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.
干预措施: Extubation Advisor (Device)
Standard of Care Arm
Participants will undergo SBTs as directed by clinicians. The EA device will not be used.
结局指标
主要结局
Evaluate the feasibility of enrolling 1-2 patients per centre per month
时间窗: Upon study completion, 12 months after study initiation
Feasibility of patient enrolment will be evaluated by determining if 1-2 patients are enrolled per centre per month.
次要结局
- Evaluate feasibility of consenting greater than 75% of eligible patients(Upon study completion, 12 months after study initiation)
- Evaluate feasibility of randomizing greater the 95% of consented patients(Upon study completion, 12 months after study initiation)
- Evaluate feasibility of generating and delivering greater than 80% of EA reports to the attending physician(Upon study completion, 12 months after study initiation)
- Evaluate feasibility of crossovers between the intervention and control arms occurring less than 10% of the time(Upon study completion, 12 months after study initiation)
- Evaluate usefulness of EA reports(Upon study completion, 12 months after study initiation)
- Evaluate feasibility of collecting complete patient outcomes greater than 90% of the time(Upon study completion, 12 months after study initiation)
- Evaluate institutional costs required to implement the EA device(Upon study completion, 12 months after study initiation)
- Evaluate the time required by respiratory therapists to implement the EA device(Upon study completion, 12 months after study initiation)
- Evaluate the time required by research coordinators to implement the EA device(Upon study completion, 12 months after study initiation)