Prospective, Interventional Multicentre Study on the Effect of Deepening of Sedation on Intra-abdominal Pressure
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intra-abdominal pressure
研究概览
简要总结
The purpose of this study is to evaluate the effect of deepening of sedation on intra-abdominal pressure in mechanically ventilated adult patients with intra-abdominal hypertension.
详细描述
The importance of intra-abdominal pressure (IAP) in critically ill patients has been addressed increasingly. Several studies have shown that elevated mean IAP is associated with adverse ICU outcomes. The prevalence of intra-abdominal hypertension (IAH) among critically ill patients is as high as 50% if defined according to maximal IAP and half of it if defined according to mean IAP. Development of IAH during ICU period is an independent risk factor for death. Considering such significant impact on patients' outcome, international conference of experts has agreed and published recommendations for treatment of IAH and abdominal compartment syndrome. Among others, deepening of sedation is suggested as treatment option. The recommendation is based on expert opinion; there are no controlled clinical studies available to support this approach. Importantly, recent studies have shown that deep sedation itself may be associated with worse outcome to patients. Treggiari et al suggest that a strategy of light sedation affords benefits with regard to reduction of intensive care unit stay and duration of ventilation without negatively affecting subsequent patient mental health or patient safety. Others have shown reduced ICU mortality as well as reduced incidence of ventilator-associated pneumonia in conjunction with light sedation.
This is a prospective, interventional, multicentre study. There will be no control group.
Study subjects:
Adult, mechanically ventilated patients with IAP between 12 and 20 mmHg in at least two consecutive measurements, spontaneous breathing activity of at least 6 breaths/minute, RASS score between 0 and -4, if no contraindications to propofol administration are present and no other interventions to reduce IAP are planned.
Study intervention:
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
- 否
入选标准
- •Age 18 years or older
- •Mechanical ventilation
- •IAP between 12 and 20 mmHg in at least two consecutive measurements within 1-12 h
- •Spontaneous breathing activity of at least 6 breaths/minute
- •RASS score between 0 and -4
- •Physician-led sedation (if sedated; as opposed to nurse-led protocol)
排除标准
- •Contraindication for propofol administration
- •Contraindication for IAP measurement in supine position with head-of-bed at 0°
- •Other intervention for reduction of IAP planned
- •Previous propofol infusion rate >4 mg/kg/h
研究组 & 干预措施
All enrolled patients
Study population:
Adult, mechanically ventilated patients with IAP between 12 and 20 mmHg in at least two consecutive measurements, spontaneous breathing activity of at least 6 breaths/minute, RASS score between 0 and -4, if no contraindications to propofol administration are present and no other immediate interventions to reduce IAP are planned
Intervention: Deepening of sedation Deepening of sedation will be achieved with a bolus of propofol followed by continuous infusion for one hour.
干预措施: Deepening of sedation (Procedure)
All enrolled patients
Study population:
Adult, mechanically ventilated patients with IAP between 12 and 20 mmHg in at least two consecutive measurements, spontaneous breathing activity of at least 6 breaths/minute, RASS score between 0 and -4, if no contraindications to propofol administration are present and no other immediate interventions to reduce IAP are planned
Intervention: Deepening of sedation Deepening of sedation will be achieved with a bolus of propofol followed by continuous infusion for one hour.
干预措施: Propofol (Drug)
结局指标
主要结局
Intra-abdominal pressure
时间窗: At 30 minutes after the start of deepening of sedation (propofol bolus)
次要结局
- Mean arterial pressure(After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol)
- Intra-abdominal pressure(After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol)
- Spontaneous and total respiratory rate(After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol)
- Abdominal perfusion pressure(After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol)
- Richmond Agitation-Sedation Scale(After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol)
- Tidal volume(After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol)
- PEEP, Ppeak, Pplat(After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol)
- Total number of vasopressor and inotrope boluses(During the intervention)
- Maximal increase in dose of noradrenaline(During the intervention)
研究者
Joel Starkopf
Professor of Anaesthesiology and Intensive Care
Tartu University Hospital