ARDS (Acute Respiratory Distress Syndrome), Critical Illness, Respiratory Failure, VILI (Ventilator-induced Lung Injury)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEREal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically
Patients in the intervention arm will receive real-time ventilator waveform monitoring through the respiratory dynamics monitoring and feedback RemoteVentilate ViewTM system. The system continuously collects high-frequency waveform data (flow, pressure, volume) directly from the ventilator interface and analyses the following metrics: Tidal volume (VT) indexed to predicted body weight, Driving pressure (ΔP), Plateau pressure (Pplat), and Mechanical power (MP). Patient-ventilator asynchrony (PVA) events will be also collected in the system, including double triggering, ineffective efforts, reverse triggering, and flow starvation, etc..
OTHERStandard ICU care
The control group will receive standard ICU care, including routine monitoring of ventilator parameters such as tidal volume, plateau pressure, and oxygenation status. No structured feedback or external ventilation reports will be provided. This reflects the prevailing standard of care in Chinese ICUs and is thus an appropriate comparator for assessing the added value of a real-time respiratory feedback platform.
Sponsors
Peking Union Medical College Hospital
Beijing Hepingli Hospital
Beijing No.6 Hospital
Jinzhou Medical University
Henan Provincial People's Hospital
Binzhou Second People's Hospital
Chongqing General Hospital
Qujing Central Hospital of Yunnan Province
Shandong Provincial Hospital
Capital Medical University Affiliated Beijing Anzhen Hospital, Nanchong Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomized 1:1 to intervention or control using computer-generated block randomization with stratification by study site. In the intervention group, patients will receive real-time ventilator waveform monitoring via the RemoteVentilate View™ system, which acquires ventilator flow, pressure, and volume data and computes tidal volume (VT) indexed to predicted body weight, driving pressure, plateau pressure, and mechanical power. Patient-ventilator asynchrony events are automatically detected. The system provides real-time monitoring and structured feedback reports to clinicians, while treatment decisions remain under ICU team responsibility. In the control group, patients receive standard ICU care with conventional ventilator monitoring. No access to the platform or feedback reports is provided.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Receipt of extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation at screening * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The daily lung-protective ventilation achievement rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days at day 28 (VFD-28) | Day 28 after trial enrollment | defined as the number of days alive and free from invasive mechanical ventilation between randomisation and day 28, with patients who die before day 28 considered as having 0 VFDs; |
| ICU length of stay | 28 days after ICU admission | total number of days from ICU admission to ICU discharge; |
| Serum concentration of interleukin-1 beta (IL-1β) | Baseline (within 24hours) and 72 hours after trial enrollment | Serum IL-1β concentration measured using standardized immunoassays. |
| Serum concentration of interleukin-6 (IL-6) | Baseline (within 24hours) and 72 hours after trial enrollment | Serum IL-6 concentration measured using standardized immunoassays. |
| Serum concentration of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) | Baseline (within 24hours) and 72 hours after trial enrollment | Serum sTREM-1 concentration measured using standardized immunoassays. |
| Incidence of ventilator-associated pneumonia (VAP) | 72 hours after trial enrollment | based on CDC criteria, adjudicated by two independent reviewers; |
| Incidence of barotrauma | 72 hours after trial enrollment | including pneumothorax, pneumomediastinum, or subcutaneous emphysema confirmed radiographically |
| ECMO initiation rate | 72 hours after trial enrollment | proportion of patients who require extracorporeal support during the index ICU stay; |
| Mortality at day 28 | Day 28 after trial enrollment | all-cause mortality; |
| Modified NASA Task Load Index (NASA-TLX) score (0-100) | 72 hours after trial enrollment | Six-domain modified NASA-TLX; each domain rated 0-20; performance reverse-scored; mean transformed to 0-100; higher scores indicate greater perceived workload. |
| Clinician-reported usability score (mean of 5-item, 5-point Likert scale; range 1-5) | 72 hours after trial enrollment | Five items rated 1-5; mean score reported; higher scores indicate better perceived usability. |
Countries
China
Contacts
CONTACTLongxiang Su, Doctor
Outcome results
None listed