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临床试验/NCT03243539
NCT03243539进行中(未招募)不适用

Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury

Colin Grissom2 个研究点 分布在 1 个国家目标入组 728 人开始时间: 2017年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
728
试验地点
2
主要终点
Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW

研究概览

简要总结

Patients who experience lung injury are often placed on a ventilator to help them heal; however, if the ventilator volume settings are too high, it can cause additional lung injury. It is proven that using lower ventilator volume settings improves outcomes. In patients with acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes and higher breathing rates are sometimes required to maintain a normal partial pressure of carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both important for patients with acute brain injury. The investigators have designed a computerized ventilator protocol in iCentra that matches the current standard of care for mechanical ventilation of patients with acute brain injury by targeting a normal partial pressure of carbon dioxide with the lowest ventilator volume required.

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a standard of care mechanical ventilation protocol for patients with acute brain injury in the iCentra electronic medical record system at Intermountain Medical Center. We hypothesize that implementation of a standardized neuro lung protective ventilation protocol will be feasible, will achieve a target normal partial pressure of carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight, and will improve outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury.
  • Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital
  • Age ≥ 18 years

排除标准

  • Transition to comfort care in the emergency department or on the same day of admission to the ICU
  • Death on the same day of admission to the emergency department or ICU

研究组 & 干预措施

Lung Protective Ventilation

Experimental

Subjects with acute brain injury (traumatic brain injury and non-traumatic brain injury) will receive neuro lung protective ventilation which targets a normal arterial partial pressure of carbon dioxide with the lowest tidal volume possible (6 to 8 ml/kg predicted body weight). Protocols for oxygenation and weaning from the ventilator will also be followed.

干预措施: Lung Protective Ventilation (Procedure)

结局指标

主要结局

Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW

时间窗: Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days

次要结局

  • Costs of Care(Day of admission to day of discharge, an average of 10 days)
  • Hospital, 28-Day, and 90-Day Mortality(Hospital admission through 90 days)
  • Health Care Utilization(Day of admission to day of discharge, an average of 10 days)
  • Quality of Life - up to 1 year after day of discharge(Day of admission until up to 1 year after day of discharge)
  • Hospital Discharge Disposition(Day of hospital discharge, an average of 10 days after admission)
  • Ventilator-free days to day 28(Initiation of mechanical ventilation to day 28)
  • Proportion of time with a target PaCO2 of 35 to 45 mm Hg(Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days)
  • Time to First ICU Activity(Day of admission to day of first ICU activity, an average of 0.2 days)
  • Hospital, ICU Length of Stay(Day of admission to day of discharge, an average of 10 days)
  • Average number of protocol deviations for all subjects (protocol compliance)(Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days)

研究者

发起方
Colin Grissom
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Colin Grissom

Co-Medical Director Shock Trauma ICU

Intermountain Health Care, Inc.

研究点 (2)

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