Decision Support System to Evaluate VENTilation in ARDS (DeVENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 3
- 主要终点
- Average Driving pressure delivery by the mechanical ventilator
研究概览
简要总结
Patients with Acute Respiratory Distress Syndrome (ARDS) residing in the intensive care unit (ICU) often require support for their breathing from a mechanical ventilator to provide adequate gas exchange, and although it is life-saving in this setting, it is also known to contribute to the morbidity and mortality in the condition.
Mechanical ventilation delivers a volume and pressure of gas for each breath and can vary oxygen levels. Selecting the correct oxygen, pressure and volume levels is important, as incorrect levels can harm the patient, and result in an increased time connected to the ventilator.
Recently, a system has been developed (the Beacon Caresystem) which advises the healthcare practitioner by the bedside as to how to best set the ventilator. This system is based on mathematics which describes the patients disease and may therefore provide ventilator settings which better suit the individual.
The purpose of this study is to compare mechanical ventilation in ARDS patients following advice from the Beacon Caresystem to that of standard care to investigate whether the use of the system results in improved ventilation in all severities and phases of ARDS and thus reducing morbidity in ARDS. The investigators plan to recruit 110 patients (50 in the UK and 30 in each of the other 2 sites). The study also aims to examine the biological and physiological factors that determine the worsening of ARDS and the processes involved in recovery from ARDS with the aim to develop new therapies to help detect the condition and improve recovery.
The investigators will utilise all raw data will be collected from the Beacon Caresystem to physiologically characterise the progression and resolution phases of ARDS.
Additionally blood and Urine samples will be taken from healthy volunteers (100 in total) as a control comparison group for the biological analyses carried out in the DeVENT study.
详细描述
The study is a randomised control trial, comparing the effects of mechanical ventilation in ARDS provided as standard care, with mechanical ventilation set according to the advice of the Beacon Care system. The study will compare if the use of the system results in a better application of PEEP and driving pressure across all severities and phases of ARDS.
The broad timeframe for the study is as follows. The study will be conducted at three sites. Two of these sites are outside the UK, one in France and one in Italy.
The systems will be delivered and installed starting September/October 2019 in the UK site, followed by France and Austria in November 2019. A one month period of training will then follow where all doctors and nurses involved in using the system will be trained. During this period none of the systems advice will be applied. This training will be supported by study partners, and nurses trained as super users of the system, by Mermaid Care A/S, the company producing the system, and by project investigators who have previously conducted studies using the system.
Patient inclusion and data collection will be performed at in the UK sites over a 15 month period from start October 2019 to January 2020. In both European sites, inclusion and data collection will be performed over a 12 month period from start January 2020 to December 2020. Final data analysis and report writing will be performed by March 2021.
For all study sites, all adult patients diagnosed with ARDS in the cardio-thoracic intensive care unit (ICU) undergoing mechanical ventilation will be considered to see if they are eligible for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Invasive mechanical ventilation.
- •Within 1 week of a known clinical insult or new or worsening respiratory symptoms
- •Chest radiograph with bilateral infiltrates consistent with evidence of pulmonary oedema but not fully explained by cardiac failure.
- •Hypoxaemia as defined by PaO2/FiO2 of ≤ 300mmHg (or ≤ 40kPa) (pre-ECMO PaO2/FiO2 will be used should patient be placed on extracorporeal support).
排除标准
- •Age < 18 years old.
- •The absence of an arterial catheter for blood sampling at study start.
- •Consent declined.
- •Over 7 days of mechanical ventilation.
- •Treatment withdrawal imminent within 24 hours.
- •DNAR (Do Not Attempt Resuscitation) order in place
- •Severe chronic respiratory disease requiring domiciliary ventilation (except for sleep disordered breathing)
- •Veno-Arterial ECMO
- •Healthy Volunteer Sample collection:
- •Inclusion Criteria
- •18 years or older
- •Able to consent
- •Have mental capacity
- •Exclusion Criteria
- •Blood borne viruses: HIV, Hep B, Hep C
- •Blood taken in the last 7 days
- •Under doctor for investigation
- •Haematological disease
- •Currently suffers from infection
- •Needle phobia
- •Problems with veins / vessels
研究组 & 干预措施
Intervention: Device attached with advice activated
Beacon Caresystem device will be attached to the patients and its ventilator advice will be activated.
干预措施: Beacon Caresystem device with advice (Device)
Control: standard care with device attached without advice
Beacon Caresystem device will be attached to the patients however the ventilator advice will be deactivated.
干预措施: Beacon Caresystem device without advice activated (Device)
结局指标
主要结局
Average Driving pressure delivery by the mechanical ventilator
时间窗: 18 months
To assess the average driving pressure delivered by the mechanical ventilator over the period of time when ARDS ventilation management is advised by the Beacon Caresystem as compared to standard care.
次要结局
- Daily Average physiological status - ventilation (tidal volume)(18 months)
- Daily Average physiological status(18 months)
- Daily Average physiological status - metabolism (VO2, VCO2)(18 months)
- Daily Average physiological status - pulmonary mechanisms (mean airway pressure)(18 months)
- Daily Average physiological status - end-expiratory lung volume(18 months)
- Number of times the advice from the Beacon system is followed(18 months)
- Daily Average physiological status - oxygenation (SpO2)(18 months)
- Daily Average physiological status - ventilation (anatomical dead space)(18 months)
- Daily average ventilatory ratio over time(18 months)
- Ventilator free days at 28 days.(28 days)
- Time from control mode to support mode(18 months)
- Percentage of time in control mode ventilation(18 months)
- Percentage of time in support mode ventilation(18 months)
- Mortality at 1 year(1 year)
- Number of patients with ventilation related complications(18 months)
- Daily Average physiological status - end-tidal CO2 fraction (FE'CO2)(18 months)
- Daily Average physiological status - PaO2/FiO2(18 months)
- Daily average calculated delivered pressure over time(18 months)
- Number of changes in ventilator settings per day(18 months)
- Total duration of mechanical ventilation(18 months)
- Timing, incidence and duration of ECMO(18 months)
- Timing, incidence and duration of neuromuscular blockade(18 months)
- Mortality at 28 days(28 days)
- Mortality at 6 months(6 months)
- Device malfunction event rate(18 months)
- Daily Average physiological status - ventilation (respiratory rate)(18 months)
- Daily average calculated oxygenation index over time(18 months)
- Incidence and duration of proning events and pre- and post- respiratory physiology(18 months)
- Composite endpoint including any cause of death at 28 days and days free of mechanical ventilation within 28 days among survivors(28 days)
- Proportion of breaths dysyncronous with the ventilator(18 months)
- Changes in tidal volume over time(18 months)
- Changes in Positive End Expiratory Pressure (PEEP) setting over time(18 months)
- Daily and cumulative fluid balance.(18 months)
- Organ failure assessment (SOFA) score and/or delta SOFA(28 days)
- Daily Average physiological status - shunt fraction(18 months)
- Daily average calculated mechanical power over time(18 months)