Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Critically Ill Patients
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 208
- 主要终点
- The daily lung-protective ventilation achievement rate
概览
简要总结
The REALVENT trial is designed to evaluate whether a real-time, algorithm-driven ventilation feedback strategy can improve lung-protective ventilation (LPV) achievement rates in critically ill patients receiving invasive mechanical ventilation. This multicentre randomised controlled trial will compare real-time respiratory waveform monitoring with automated feedback against standard ICU care. The primary endpoint is the LPV achievement rate over the first 72 hours.
详细描述
Mechanical ventilation is essential in modern intensive care but may cause ventilator-induced lung injury (VILI) when delivered with excessive tidal volume, airway pressure, or mechanical power, or in the presence of unrecognised patient-ventilator asynchrony. Despite guideline recommendations to limit tidal volume, plateau pressure, and driving pressure, real-world adherence to lung-protective ventilation (LPV) remains suboptimal, and clinicians often rely on intermittent, manual review of ventilator settings and waveforms.
The REALVENT trial tests a cloud-based respiratory dynamics monitoring and feedback system that continuously acquires high-frequency ventilator waveforms (pressure, flow, volume) and automatically computes key LPV metrics, including tidal volume indexed to predicted body weight, driving pressure, plateau pressure, mechanical power, and patient-ventilator asynchrony events. For patients in the intervention arm, the platform provides three layers of feedback over the first 72 hours after randomisation: (1) real-time alerts when LPV thresholds are exceeded; (2) 4-hour window indicator checks to capture sustained deviations; and (3) standardised 24-hour summary reports with recommendations for ventilator adjustment. These reports are reviewed by bedside clinicians and a central monitoring team, but all treatment decisions remain at the discretion of the local ICU team.
The control group receives usual care with standard bedside ventilator monitoring but without structured feedback from the platform. All other aspects of care, including fluid management, sedation, prone positioning, neuromuscular blockade, and adjunct respiratory monitoring (e.g., esophageal manometry or EIT), are left to clinician judgement and recorded.
The primary hypothesis is that algorithm-driven feedback will increase the proportion of time during the first 72 hours that all four LPV targets are simultaneously achieved compared with standard care. Secondary hypotheses are that improved LPV adherence will translate into more ventilator-free days, fewer ventilator-associated complications, lower inflammatory biomarker levels, and acceptable clinician workload and usability ratings.
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
Due to the nature of the intervention, treating clinicians and bedside staff will not be blinded to group allocation. The real-time feedback reports and alerts generated by the respiratory dynamics monitoring and feedback RVV systemTM are inherently visible to the ICU team and require bedside review and interpretation, precluding clinician blinding. However, the following personnel will remain blinded to group allocation throughout the study: ①Outcome assessors (data analysts reviewing ventilator-free days, inflammatory biomarkers detection, VAP, barotrauma, mortality); ②The core biostatistical team responsible for primary and secondary outcome analyses; ③Members of the independent Data Monitoring Committee (DMC) reviewing interim safety data.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Receiving invasive mechanical ventilation via endotracheal intubation at the time of screening
- •Initiation of invasive mechanical ventilation within the past 24 hours
- •PaO₂/FiO₂ ≤ 200 mmHg on PEEP ≥ 8 cmH₂O or, if arterial blood gas is unavailable: SpO₂/FiO₂ ≤ 235 with SpO₂ ≤ 97%
- •Chest imaging (chest X-ray or CT) showing bilateral pulmonary infiltrates not fully explained by pleural effusions, lobar collapse, or pulmonary nodules
- •Respiratory failure not fully explained by cardiac failure or fluid overload
- •Expected to require invasive mechanical ventilation for ≥ 72 hours after enrollment
排除标准
- •Receipt of extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation at screening
- •Chronic ventilator dependence, defined as ≥ 21 consecutive days of mechanical ventilation prior to the current admission
- •Brain death or anticipated withdrawal of life-sustaining treatment within 72 hours
- •Pregnancy
- •Known neuromuscular disease affecting spontaneous respiratory effort
- •Prisoners or individuals unable to provide informed consent or surrogate consent
- •Simultaneous enrollment in another interventional ICU study
- •Lack of digital infrastructure for real-time ventilator waveform acquisition
结局指标
主要结局
The daily lung-protective ventilation achievement rate
时间窗: Over the first 72 hours following randomisation
The primary outcome is the daily lung-protective ventilation achievement rate over the first 72 hours following randomisation. Lung-protective ventilation is defined as simultaneous fulfilment of all of the following four criteria: Tidal volume (VT) \< 8 mL/kg predicted body weight (PBW); Driving pressure (ΔP) \< 15 cmH₂O; Plateau pressure (Pplat) \< 30 cmH₂O; Mechanical power (MP) \< 17 J/min. The daily achievement rate is calculated as the number of hours within each 24-hour period where all four targets are met, divided by 24, and expressed as a percentage. The mean of the three daily rates over the 72-hour period will be used as the primary outcome. This outcome reflects both physiological safety and clinician behaviour, and was selected based on its strong mechanistic link with ventilator-induced lung injury and previous observational data on variability in adherence
次要结局
- Ventilator-free days at day 28 (VFD-28)(Day 28 after trial enrollment)
- Serum concentration of interleukin-1 beta (IL-1β)(Baseline (within 24hours) and 72 hours after trial enrollment)
- Modified NASA Task Load Index (NASA-TLX) score (0-100)(72 hours after trial enrollment)
- Incidence of barotrauma(72 hours after trial enrollment)
- ICU length of stay(28 days after ICU admission)
- Clinician-reported usability score (mean of 5-item, 5-point Likert scale; range 1-5)(72 hours after trial enrollment)
- Serum concentration of interleukin-6 (IL-6)(Baseline (within 24hours) and 72 hours after trial enrollment)
- Serum concentration of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1)(Baseline (within 24hours) and 72 hours after trial enrollment)
- Incidence of ventilator-associated pneumonia (VAP)(72 hours after trial enrollment)
- ECMO initiation rate(72 hours after trial enrollment)
- Mortality at day 28(Day 28 after trial enrollment)