The Full Closed Loop Ventilation Mode INTELLiVENT-ASV: User-friendly and Effective Mechanical Ventilation in High Risk Postoperative Patient on the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Percentage (%) of mechanical ventilation time in an optimal, acceptable or unacceptable ventilation zone.
研究概览
简要总结
The aim of this study is to investigate whether postoperative ventilation with INTELLiVENT-ASV(adaptive support ventilation) in high risk patients, after cardiothoracic surgery, is as effective, more user-friendly and as safe as compared to the conventional modes of ventilation.
详细描述
Recently, Hamilton Medical has introduced the new mechanical ventilation mode "INTELLiVENT-ASV". This is a fully closed ventilation mode that can automatically adjust the ventilation settings based on the measured End tidal CO2 (ETCO2) and the measured saturation (SpO2) in both passive and active ventilated patients. Current literature has shown that this mode is safe to use in patients admitted on the intensive care unit. A pilot study in the Catharina Hospital Eindhoven confirmed that in postoperative low risk patients on the intensive care unit INTELLiVENT-ASV is safe. Compared to continuous mandatory or pressure controlled ventilation with pressure support (conventional mechanical ventilation), INTELLiVENT-ASV is even as effective as conventional mechanical ventilation, with a significantly reduced number of interactions with the ventilator. However, available research about the effectiveness of INTELLiVENT-ASV in postoperative high risk patients is lacking. Also the knowledge about the user-friendliness of the above modes of mechanical ventilation for the users is lacking.
This is a prospective randomized study with a control group and a intervention group of postoperative high risk patients. Through randomization will be determined whether the participant, after surgery, will be mechanically ventilated with INTELLiVENT-ASV and Quickwean or with conventional mechanical ventilation.
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
- Single (Outcomes Assessor)
盲法说明
The participant will not know which ventilation mode will be or is used. The primairy investigator and care providers are aware of which ventilation mode is used since it is not possible to blind the care providers because they will need to change ventilating parameters if necessary.
The outcome assesor for the percentages of time will be masked. Also are the radiologists, who judge the postoperative thoracic x-ray, masked.
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 above 18 years of age.
- •Informed consent.
- •Body mass index of <35 kg/m
- •Mechanical ventilation after elective cardiothoracic surgery.
- •Admission of the patient after surgery is on the high care unit of the intensive care ward for postoperative mechanical ventilation.
排除标准
- •Withdrawal of consent
- •Medical history of a pneumonectomy or lobectomy.
- •The patient wit acute respiratory distress syndrome after surgery.
- •The patient with a medical history of COPD Gold 3 or
- •The patient is participating in another postoperative study performed on the intensive care.
- •The patient is, preoperatively determined, eligible for a fast-track postoperative treatment program on the Post Anesthesia Care Unit.
研究组 & 干预措施
INTELLiVENT-ASV
INTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton.
干预措施: INTELLiVENT-ASV (Device)
Conventional modes
Volume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device.
干预措施: Conventional modes (Device)
结局指标
主要结局
Percentage (%) of mechanical ventilation time in an optimal, acceptable or unacceptable ventilation zone.
时间窗: During the first 3 hours, since admission on the ICU with the start of the intervention ventilation mode.
* An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = \<31cmH2O and SpO2 = 93-98%. * An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or \>98%. * An unacceptable zone = TV \>12 ml/kg of PBW or an EtCO2 = \<25 or \>50mmHg, plateau pressure \>35 cmH2O or SpO2 = \<85%.
次要结局
- The percentage (%) of successful extubations.(During the first 24, 48 and 72 hours after extubation)
- Postoperative atelectasis(Up to 48 hours after extubation)
- Administration of sedatives and analgesics(Up to 72 hours of mechanical ventilation time)
- O2 levels for postoperative pulmonary shunting(Up to 72 hours of mechanical ventilation time)
- Postoperative weaning time(72 hours)
- Workload(72 hours)
- The Richmond Agitation-Sedation Scale (RASS)(Up to 72 hours of mechanical ventilation time)
- CO2 levels for postoperative pulmonary shunting(Up to 72 hours of mechanical ventilation time)
- Reliability of non-invasive oxygen saturation measurement(72 hours)
- Usability(Up to 1 day after extubation)
- Patient agitation(Up to 72 hours of mechanical ventilation time)
研究者
Ashley De Bie
MSc.
Catharina Ziekenhuis Eindhoven