Automated Control of Mechanical Ventilation During General Anaesthesia - A Bicentric Prospective Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Frequency of adverse events.
研究概览
简要总结
Prospective, bicentric observational study to assess a novel system for automated control of mechanical ventilation (Smart Vent Control, SVC) during general anesthesia.
详细描述
The "Automated control of mechanical ventilation during general anesthesia study (AVAS study) is an international investigator-initiated bicentric observational study investigating the application of Smart Vent Control (SVC) during general anesthesia. The main objective of this study is to describe the application of SVC and to assess its safety and efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Planned elective surgery of the upper limb, lower limb or peripheral vascular surgery in general anesthesia
- •Patient is classified as American Society of Anesthesiologists physical status (ASA) I, II or III
- •Age ≥ 18 years
- •Written consent of the patient for study participation
排除标准
- •Mild, moderate or severe acute respiratory distress syndrome (ARDS)[10]
- •Known chronic obstructive pulmonary disease Gold stage III or higher
- •Two or more of the following organ failures
- •Mild, moderate or severe ARDS
- •Hemodynamic instability: systolic blood pressure < 90 mm Hg, mean arterial pressure < 70 mm Hg or administration of any vasoactive drugs.
- •Acute renal failure: oliguria (urine output < 0.5 ml/kg/h for at least 2 hours despite of adequate management or creatinine increase > 0.5 mg/dl
- •Cerebral failure: loose of consciousness or encephalopathy
- •Patient is pregnant.
结局指标
主要结局
Frequency of adverse events.
时间窗: During artificial ventilation with SVC (up to 8 hours).
* Severe hypoventilation defined as minute volume lower than 40 ml/kg predicted body weight for longer than 5 minutes * Apnea for longer than 90 seconds * Hyperventilation defined as PetCO2 lower than 5 mm Hg of the lower target setting for SVC for longer than 5 minutes * Hypoventilation defined as PetCO2 higher than 5 mm Hg of the upper target setting for the SVC for longer than 5 minutes * Respiratory rate \> 35 breaths per minute for longer than 5 minutes * Any override or stop of the automated controlled ventilation settings by the anesthesiologist in charge if the settings are clinically not acceptable. Reasons for overriding or stopping the system will be noted.
次要结局
- Frequency distribution of tidal volume (ml/kg predicted body weight).(During artificial ventilation with SVC (up to 8 hours).)
- Frequency distribution of PetCO2 (mmHg).(During artificial ventilation with SVC (up to 8 hours).)
- Frequency distribution of expiration time (s).(During artificial ventilation with SVC (up to 8 hours).)
- Proportion of time within the target zones for tidal volume and PetCO2 as individually set up for each patient by the user.(During artificial ventilation with SVC (up to 8 hours).)
- Frequency of alarms.(During artificial ventilation with SVC (up to 8 hours).)
- Frequency distribution of inspiratory pressure (mbar).(During artificial ventilation with SVC (up to 8 hours).)
- Number of re-intubations.(During artificial ventilation with SVC (up to 8 hours).)
- Frequency of normoventilated, hypoventilated and hyperventilated patients.(During artificial ventilation with SVC (up to 8 hours).)
- Time period between switch from controlled ventilation to augmented ventilation and achievement of stable assisted ventilation of the patient.(During artificial ventilation with SVC (up to 8 hours).)
- Frequency distribution of inspiration time (s).(During artificial ventilation with SVC (up to 8 hours).)
研究者
Norbert Weiler
Prof. Dr. Norbert Weiler
University Hospital Schleswig-Holstein