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临床试验/NCT04708509
NCT04708509已完成1 期

Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年10月4日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
31
试验地点
2
主要终点
Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients

研究概览

简要总结

Expeditious, safe extubation is vitally important in the care of Intensive Care Unit (ICU) patients, as prolonged mechanical ventilation harms patients and failed extubation (i.e. re-intubation within 48 hrs) is associated with increased morbidity, mortality and costs. The urgent need to improve extubation failure is further highlighted by current observations suggesting that COVID-19 patients are at increased risk of both early and late extubation failure. The investigators previously found that decreased respiratory rate variability (indicative of reduced adaptability and/or increased stress) during Spontaneous Breathing Trials (SBTs) predicted extubation failure and outperformed the best available predictive indices. Combining this predictive analytic with standardized extubation readiness checklists and risk mitigation strategies, the investigators created the Extubation Advisor (EA). The investigators recently completed a single-center phase I mixed methods observational study (n=117) wherein there was demonstrated technical feasibility (i.e. ability to generate 92% EA of reports) and clinician acceptance of the EA tool. In the current open-label, multi-center interventional phase I study, the investigators will assess the feasibility and initial perceptions of EA implementation in the intensive care unit by (1) evaluating the feasibility of patient enrolment, data collection, and EA report generation, and (2) performing a mixed-methods analysis of critical care physician and respiratory therapist perceptions of EA. Findings from this study will inform a future randomized controlled trial assessing EA outcomes compared to standard of care, with the intent of aiding bedside decision-making, enhancing care delivery, and improving outcomes in critically ill patients with and without COVID-19.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In the Intensive Care Unit (ICU)
  • Able to provide informed consent (through a surrogate)
  • Invasive mechanical ventilation for > 48 hours
  • Ready for spontaneous breathing test (SBT) for assessment for extubation
  • At least partial reversal of the condition precipitating mechanical ventilation
  • Stabilization of other organ systems
  • Toleration of pressure support ventilation less than or equal to 14 cm H2O, (oxygen saturation (SpO2) greater than or equal to 90% with fraction of inspired oxygen (FiO2) less than or equal to 40% and positive end-expiry pressure (PEEP) less than or equal to 10cm H2O)
  • Hemodynamic stability (low - phenylephrine less than 50 ug/min; norepinephrine less than 5 ug/min; dobutamine less than 5 ug/kg/min; milrinone less than 0.4 ug/kg/min - or no vasopressors)
  • Stable neurological status (no deterioration in Glasgow coma score during prior 24 hours and, if measured, intracranial pressure (ICP) less than 20 mmHg)
  • Intact airway reflexes (adequate cough with suctioning and a gag reflex)
  • Normal sinus rhythm at the time of the SBT (no pacemaker)

排除标准

  • Order not to re-intubate should the patient fail extubation
  • Anticipated withdrawal of life support
  • Known or suspected severe weakness (myopathy, neuropathy, or quadriplegia)
  • Tracheostomy
  • Prior extubation during current ICU stay

结局指标

主要结局

Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients

时间窗: Upon study completion, 4 months after study initiation

Feasibility of patient enrolment and consent will be evaluated by determining if greater than 50% of eligible patients are enrolled and consented

Evaluate Feasibility of Capturing Greater Than 75% of Wave Form Data

时间窗: Upon study completion, 4 months after study initiation

Feasibility of wave form data capture will be evaluated by determining if greater than 75% of the time, wave form data is captured

Evaluate Feasibility of Generating and Delivering Greater Than 80% of Extubation Advisor Reports to the Attending Physician

时间窗: Upon study completion, 4 months after study initiation

Feasibility of Extubation Advisor report generation will be evaluated by determining if greater than 80% of the time, an extubation report is successfully generated and delivered to the attending physician

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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