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临床试验/NCT00793013
NCT00793013撤回2 期

Primary Resuscitation Using Airway Pressure Release Ventilation Improves Recovery From Acute Lung Injury or Adult Respiratory Distress Syndrome and Reduces All Cause Mortality Compared to ARDS Net Low Tidal Volume-Cycled Ventilation.

University of Tennessee, Chattanooga2 个研究点 分布在 1 个国家开始时间: 2020年11月2日最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
发起方
试验地点
2
主要终点
All cause mortality

研究概览

简要总结

Traditional modes of ventilation have failed to improve patient survival. Subsequent observations that elevated airway pressures observed in traditional forms of ventilation resulted in barotrauma and extension of ALI lead to the evolution of low volume cycled ventilation as a potentially better ventilatory modality for ARDS. Recent multicenter trials by the NIH-ARDS network have confirmed that low volume ventilation increases the number of ventilatory free days and improves overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.

详细描述

Low volume ventilation may increase number of ventilatory free days and may improve overall patient survival. While reducing mean airway pressure has reduced barotrauma and improved patient survival, it has impaired attempts to improve alveolar recruitment. Alveolar recruitment is important as it improves V/Q mismatch, allows reduction in FIO2 earlier, and decreases the risk of oxygen toxicity. Airway pressure release ventilation (APRV) is a novel ventilatory modality that utilizes controlled positive airway pressure to maximize alveolar recruitment while minimizing barotrauma. In APRV, tidal ventilation occurs between the increase in lung volumes established by the application of CPAP and the relaxation of lung tissue following pressure release. Preliminary studies have suggested that APRV recruits collapsed alveoli and improves oxygenation through a restoration of pulmonary mechanics, but there are no studies indicating the potential overall benefit of APRV in recovery form ALI/ADRS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients admitted to the Internal Medicine service at the Baroness Erlanger Hospital of the University of Tennessee College of Medicine with hypoxia (O2 saturation < 93%) and pulmonary distress, will be screened for study participation.
  • Patients displaying all the following clinical criteria: acute onset of respiratory failure; hypoxia defined as a PaO2/FiO2 ratio of < 300 Torr; pulmonary capillary wedge pressure less or equal than 18 mm Hg, and/or no clinical evidence of left sided heart failure; and chest x-ray with diffuse bilateral pulmonary infiltrates.

排除标准

  • Patients receiving conventional volume ventilation with or without PEEP for > 6 hours prior to study enrollment
  • Patient's family or surrogate unwilling to give informed consent
  • Patients requiring sedation or paralysis for effective ventilation
  • Patients known pulmonary embolus within 72 hours of study enrollment
  • Patients with close head injuries or evidence of increased intracranial pressure
  • Patients with burns over 30% of total body surface area
  • Pulmonary capillary wedge pressure greater than 18 mm Hg
  • CVP > 15 cm H2O
  • Patients with B type Naturetic peptide levels > 1000
  • Patients with prior history of dilated cardiomyopathy with EF < 25%
  • Patients receiving chronic outpatient peritoneal or hemodialysis
  • Patients with severe liver disease (as defined by Child-Pugh class C)
  • AIDS patients

结局指标

主要结局

All cause mortality

时间窗: 28 days or prior to hospital discharge

次要结局

  • Number of ventilator-free days(28 days or prior to hospital discarge)
  • To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the incidence of of AKI(28 days or prior to hospital discharge)
  • To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the NGAL, KIM-1, and IL-18 urine biomarkers for AKI(28 days or prior to hospital discharge)
  • To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation in maintaining hourly urine output > 0.5 mls/kg/hr(28 days or prior to hospital discharge)
  • Length of ICU stay and /or Total hospital days(28 days or prior to hospital discharge)
  • Will determine urinary aquaporin-2 levels in patients randomized to APRV ventilation versus ARDS net low volume-cycle ventilation(28 days or prior to hospital discharge)

研究者

发起方
University of Tennessee, Chattanooga
申办方类型
Other
责任方
Sponsor

研究点 (2)

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