A Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Fully Automated Closed-loop Ventilator Versus Conventional Open-loop Ventilator in Ventilated Patients in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 主要终点
- Duration of ventilation within a predefined range of acceptable respiratory parameters
研究概览
简要总结
Patients presenting to the emergency department (ED) may require breathing support with machines depending on the condition. Throughout the breathing support, the settings on the breathing machines will be tailored to the patient's requirements. These settings are manually adjusted by trained physicians. Currently, there are machines which can automatically change the settings based on real-time specific information obtained from the patient. This study aims to compare the use of machines which require manual adjustments (open-loop conventional ventilators) and machines which can automatically change the settings (closed-loop automated ventilators). Patients will be carefully selected to ensure no harm is caused whilst delivering the best care. This study will look into the duration when patients are receiving optimum settings and levels of oxygen and carbon dioxide in the blood. The outcomes of this study would allow us to identify methods to improve patient care.
详细描述
Invasive mechanical ventilation is a lifesaving intervention for patients with respiratory failure in the emergency department (ED). Recent technological advancements have introduced closed-loop automated ventilators as a potential alternative to open-loop conventional ventilators. However, the efficacy and safety of closed-loop automated ventilators in the emergency setting remains understudied. This research aims to evaluate the efficacy and safety of closed-loop automated ventilator compared to open-loop conventional ventilator in intubated and ventilated patients in the ED.
A randomized controlled trial will be conducted in an ED of a tertiary university-affiliated hospital. Eligible patients are 18 years or older, decision made by treating physicians to intubate and mechanically ventilate. Some of exclusion criteria are pregnancy, heart failure, metabolic acidosis, circulatory shock, life-threatening asthma and morbid obesity. The primary measure of efficacy is the duration of ventilation within a predefined range of acceptable respiratory parameters between automated and conventional ventilation. Secondary outcome measures are; number of manual adjustments required to attain targeted settings in automated and conventional ventilators, PaO2/FiO2 ratio (PF ratio), arterial blood gas results, vital signs, breath-by-breath analysis, and rate of ventilator dyssynchrony. The ventilator used in the intervention arm is the closed-loop automated ventilator Hamilton C6s INTELLIVENT-ASV (Hamilton Medical AG, Switzerland). Hamilton C1 ASV is chosen as the open-loop conventional comparator as it is similar to Hamilton C6s INTELLIVENT-ASV, without the INTELLIVENT software.
Based on Lellouche et al, the calculated total sample size with a dropout rate of 10% is 132. The data is analysed based on the intention-to-treat (ITT) and per-protocol (PP) principles. The primary endpoint measurements are reported as areas under the curves (AUC) within the predefined range of acceptable respiratory parameters. Between-group differences in continuous variables are analysed using independent t-test or Mann-Whitney U test. Between-group differences in categorical variables are analysed using chi-square test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Decision made by treating physicians to intubate and mechanically ventilate
排除标准
- •Suspected or confirmed pregnancy.
- •Known right ventricular heart failure upon assessment for recruitment.
- •Severe metabolic acidosis upon intubation (pH <7.2 or bicarbonate <12 mmol/L)
- •Circulatory shock requiring noradrenaline more than 0.5 mcg/kg/min upon assessment for recruitment.
- •Severe or acute life-threatening asthma.
- •Patients with chest wall deformities that would affect ventilation (e.g. severe kyphoscoliosis, diaphragmatic hernia, flail chest, trauma, pectus excavatum or carinatum, ankylosing spondylitis
- •Patients with previous lobectomy or pneumonectomy.
- •Patients with pneumothorax or other condition that requires chest drainage tube.
- •Patients with body mass index > 40 kg/m
- •Manufacturer's contraindications:
- •Difference in oxygen saturation between pulse oximetry (SpO2) and arterial sample (SaO2) of more than 5% (due to unreliable sensor).
- •Difference in carbon dioxide level between end-tidal sensor (ETCO2) and arterial sample (PaCO2) of more than 5 mm Hg (due to unreliable sensor).
- •Known pneumothorax and bronchopulmonary fistula upon assessment for recruitment.
- •Participation in another interventional trial.
- •Do-not-attempt-resuscitation (DNAR) order.
研究组 & 干预措施
Open-loop ventilator
Prior to the rapid sequence intubation, patients' gender and height are set on the ventilator. The physician in-charge will setup the ventilator based on the lung condition, following the research protocol. Patients will be connected to this ventilator upon securing the airway. Ventilator setting parameters will be manually adjusted by the in-charge physician following local guidelines.
干预措施: Open-loop ventilator (Device)
Closed-loop ventilator
Prior to the rapid sequence intubation, patients' gender and height are set on the ventilator. Patients' condition settings are selected depending on the lung condition. The sensors for end-tidal carbon dioxide (EtCO2) and oxygen saturation (SpO2) will be connected. Patients will be connected to this ventilator upon securing the airway. Ventilator setting parameters will be set following the study protocol.
干预措施: Closed-loop ventilator (Device)
结局指标
主要结局
Duration of ventilation within a predefined range of acceptable respiratory parameters
时间窗: Every 30 seconds for 240 minutes
Duration of ventilation (in minutes) within predefined acceptable tidal volume (TV), plateau pressure, EtCO2 and SpO2
次要结局
- Physiological data - respiratory rate(Mean hourly for 4 hours)
- Biochemical data - CO2 and O2(Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour)
- Biochemical data - bicarbonate(Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour)
- Ventilator data - airway pressures(Every 30 seconds for 240 minutes)
- Manual adjustments of ventilator settings(Any time the manual adjustment is performed throughout the 4-hour study period)
- Physiological data - blood pressure(Mean hourly for 4 hours)
- Patient outcome - LOS hospital(Assessed from time of triage in ED to time of discharge or in-hospital death, whichever comes first up to 28 days)
- Ventilator data - FiO2(Every 30 seconds for 240 minutes)
- Patient outcome - LOS ICU(Assessed from time of admission into the ICU to time of transfer to general ward or death, whichever comes first up to 28 days)
- Biochemical data - pH(Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour)
- Mortality rate(At 14 and 28 days after recruitment)
- Number of patients developing ARDS and pneumothorax(At anytime within the 4-hour intervention or upon discharge or diagnosis of complications)
- Physiological data - heart rate(Mean hourly for 4 hours)
- Patient outcome - mechanical ventilation(Assessed from time of intubation to time of successful extubation or death from any cause, whichever came first, assessed up to 28 days)
- Patient outcome - LOS ED(Assessed from time of triage to time patient leaves ED or death, whichever comes first, up to 7 days)
研究者
Dr. Khadijah Poh Yuen Yoong
Consultant Emergency Physician
University of Malaya