Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Critically Ill Patients
REALVENT
1 other identifier
interventional
208
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2025
CompletedFirst Posted
Study publicly available on registry
December 29, 2025
CompletedStudy Start
First participant enrolled
December 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
December 29, 2025
December 1, 2025
6 months
December 2, 2025
December 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Over the first 72 hours following randomisation
Secondary Outcomes (11)
Ventilator-free days at day 28 (VFD-28)
Day 28 after trial enrollment
ICU length of stay
28 days after ICU admission
Serum concentration of interleukin-1 beta (IL-1β)
Baseline (within 24hours) and 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
- +6 more secondary outcomes
Study Arms (2)
REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically
EXPERIMENTALPatients 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
Standard ICU care
ACTIVE COMPARATORThe 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.
Interventions
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..
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Hepingli Hospitalcollaborator
- Beijing No.6 Hospitalcollaborator
- Jinzhou Medical Universitycollaborator
- Henan Provincial People's Hospitalcollaborator
- Binzhou Second People's Hospitalcollaborator
- Chongqing General Hospitalcollaborator
- Shandong Provincial Hospitalcollaborator
- Capital Medical University Affiliated Beijing Anzhen Hospital, Nanchong Centercollaborator
- Peking Union Medical College Hospitallead
- Qujing Central Hospital of Yunnan Provincecollaborator
Related Publications (4)
Liu S, Zhao Z, Chen X, Chi Y, Yuan S, Cai F, Song Z, Ma Y, He H, Su L, Long Y. Evaluation of health care providers' ability to identify patient-ventilator triggering asynchrony in intensive care unit: a translational observational study in China. BMC Med Educ. 2025 Feb 4;25(1):182. doi: 10.1186/s12909-025-06638-5.
PMID: 39905371RESULTChen X, Yuan S, Kassis EB, Zhang S, Chi Y, Liu S, Cai F, Ma Y, Li Y, Su L, Long Y. Methodological development of the remote ventilate view platform for real-time monitoring of patient-ventilator asynchrony and respiratory parameters in severe pneumonia patients. J Intensive Med. 2025 Sep 23;5(4):367-376. doi: 10.1016/j.jointm.2025.07.003. eCollection 2025 Oct.
PMID: 41180101RESULTChen X, Fan J, Zhao W, Shi R, Guo N, Chang Z, Song M, Wang X, Chen Y, Li T, Li GG, Su L, Long Y; on bahalf of Beijing Dongcheng Critical Care Quality Control Centre Group. Application of a cloud platform that identifies patient-ventilator asynchrony and enables continuous monitoring of mechanical ventilation in intensive care unit. Heliyon. 2024 Jun 27;10(13):e33692. doi: 10.1016/j.heliyon.2024.e33692. eCollection 2024 Jul 15.
PMID: 39055813RESULTSu L, Lan Y, Chi Y, Cai F, Bai Z, Liu X, Huang X, Zhang S, Long Y. Establishment and Application of a Patient-Ventilator Asynchrony Remote Network Platform for ICU Mechanical Ventilation: A Retrospective Study. J Clin Med. 2023 Feb 16;12(4):1570. doi: 10.3390/jcm12041570.
PMID: 36836113RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2025
First Posted
December 29, 2025
Study Start
December 30, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
December 29, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will become available within one year of completion of the final follow up assessment, or within one year of primary manuscript publication, whichever comes first. Data will be available for 10 years.
- Access Criteria
- Outside investigators who wish to use data will submit a formal request, including rationale, analysis plan, and local Institutional Review Board (IRB) determination. Sponsor will review and respond to all requests. All data sharing will be codified by the appropriate contract / data use agreement. Recipient researchers must promise in writing to never attempt to access identifiable health/medical information or to attempt to identify the subject(s) who provided the specimen/data. Any intent to use materials or data for commercial purposes must be clearly disclosed as part of the request.
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.