Study Title: Prospective, Multicenter, Randomized, Controlled Study Comparing Efficacy and Safety of INTELLiVENT-ASV Versus Non-automated Ventilation in Adult ICU Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Efficacy Measured as Percentage of Time Spent in Optimal Range
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of INTELLiVENT-ASV (Adaptive Support Ventilation) in adult ICU patients comparing to non automated ventilation.
详细描述
EASiVENT is a prospective, multicenter, randomized (1:1), Controlled Study. This study is single-blind because only the subject will be unaware of the ventilation modality administered. The reference treatment used for comparison is a combination of controlled modes for passive subjects (volume control or pressure control) and assisted/spontaneous modes for active subjects (synchronized intermittent mechanical ventilation or pressure support)
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight greater than 40 kg
- •Under invasive ventilation
- •Expected to be mechanically ventilated after enrollment for at least 24 hours
- •Agrees to not participate in other interventional research studies involving mechanical ventilation for the duration of study
- •Signature of the informed consent by the patient or his/her next-of-kin according to country or state regulation.
排除标准
- •Fulfilling weaning criteria according to the weaning procedure of the ICU
- •Need for "rescue therapy" (e.g: ECMO)
- •Brain death status
- •Respiratory drive disorder (Cheyne-Stokes breathing)
- •Arterial hypoxia due to a non-pulmonary condition (right-to-left shunting due to congenital disease, hepato-pulmonary syndrome, )
- •Broncho-pleural fistula
- •Chronic or acute dyshemoglobinemia: eg.: acute CO poisoning
- •Chronic respiratory failure requiring long term invasive ventilation;
- •Moribund patient
- •Patient under guardianship, deprived of liberties
- •Any other condition, that in the opinion of the IoR/designee, would preclude informed consent (by the spouse/next of kin), make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- •Low quality index on the SpO2 (Oxygen Saturation Measured by Pulse Oximetry) measurement
- •Patients already enrolled in the present study in a previous episode of acute respiratory failure
- •High PaCO2 - ETCO2 gap (> 2.6 kPa or 19.5 mmHg) for > 3 hours
- •Patient tracheostomized at the time of inclusion
- •Patient ventilated with helium
结局指标
主要结局
Efficacy Measured as Percentage of Time Spent in Optimal Range
时间窗: up to 7 days after enrollment
Objective of this study is to compare the efficacy of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of efficacy. Efficacy endpoints are composite endpoints \& are based on six variables that will be continuously recorded during the study period: These 6 variables: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as optimal when all six variables were within predefined optimal ranges
Safety Measured as Percentage of Time Spent in Sub-optimal Range
时间窗: 7 days after enrollment.
Objective of this study is to compare the safety of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of safety. Safety endpoints are composite endpoints \& are based on six variables that will be continuously recorded during the study period: sub-optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as sub-optimal when at least one of the six variables was within predefined sub-optimal ranges.
次要结局
- Fraction of Inspiration Oxygen (FiO2) (%)(up to 28 days after enrollment)
- Expiratory Time Constant (s)(up to 28 days after enrollment)
- Positive End-Expiratory Pressure (PEEP) (cm H2O)(up to 28 days after enrollment)
- Tidal Volume (ml)(up to 28 days after enrollment)
- Tidal Volume mL/kg Ideal Body Weight (IBW)(up to 28 days after enrollment)
- Ventilation - Respiratory Rate(up to 28 days after enrollment)
- Numbers of Manual Settings Changes Per Day(up to 28 days after enrollment)
- Automatic Settings Changes Per Day(up to 28 days after enrollment)