An interventional study of REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically and Standard ICU care in ARDS (Acute Respiratory Distress Syndrome), VILI (Ventilator-induced Lung Injury) and Respiratory Failure, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
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.
989 studies on the registry are indexed under Acute Lung Injury; 156 are open to participants now.
This study's planned enrollment of 208 is above the median of 54 across 561 interventional studies indexed under Acute Lung Injury.
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Exclusion Criteria:
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, ect
Device: REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically
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.
Other: Standard ICU care
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..
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.
The daily lung-protective ventilation achievement rate
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
Time frame: Over the first 72 hours following randomisation
Ventilator-free days at day 28 (VFD-28)
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;
Time frame: Day 28 after trial enrollment
ICU length of stay
total number of days from ICU admission to ICU discharge;
Time frame: 28 days after ICU admission
Serum concentration of interleukin-1 beta (IL-1β)
Serum IL-1β concentration measured using standardized immunoassays.
Time frame: Baseline (within 24hours) and 72 hours after trial enrollment
Serum concentration of interleukin-6 (IL-6)
Serum IL-6 concentration measured using standardized immunoassays.
Time frame: Baseline (within 24hours) and 72 hours after trial enrollment
Serum concentration of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1)
Serum sTREM-1 concentration measured using standardized immunoassays.
Time frame: Baseline (within 24hours) and 72 hours after trial enrollment
Incidence of ventilator-associated pneumonia (VAP)
based on CDC criteria, adjudicated by two independent reviewers;
Time frame: 72 hours after trial enrollment
Incidence of barotrauma
including pneumothorax, pneumomediastinum, or subcutaneous emphysema confirmed radiographically
Time frame: 72 hours after trial enrollment
ECMO initiation rate
proportion of patients who require extracorporeal support during the index ICU stay;
Time frame: 72 hours after trial enrollment
Mortality at day 28
all-cause mortality;
Time frame: Day 28 after trial enrollment
Modified NASA Task Load Index (NASA-TLX) score (0-100)
Six-domain modified NASA-TLX; each domain rated 0-20; performance reverse-scored; mean transformed to 0-100; higher scores indicate greater perceived workload.
Time frame: 72 hours after trial enrollment
Clinician-reported usability score (mean of 5-item, 5-point Likert scale; range 1-5)
Five items rated 1-5; mean score reported; higher scores indicate better perceived usability.
Time frame: 72 hours after trial enrollment
Plan to share: Yes — De-identified individual participant data underlying the primary and secondary outcome results (including the final trial dataset and data dictionary) may be shared with qualified investigators for methodologically sound proposals, after publication of the main results and subject to institutional and ethical approvals. Data will be shared via secure data transfer agreements and will not contain any directly identifiable information.
Supporting information: Study protocol, Icf
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Peking Union Medical College Hospital