ARDS (Acute Respiratory Distress Syndrome)REALVENTNCT07307066
Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study)
A study testing REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically and Standard ICU care in people with ARDS (Acute Respiratory Distress Syndrome) and VILI (Ventilator-induced Lung Injury), run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome), VILI (Ventilator-induced Lung Injury), Respiratory Failure
- What is being tested?
- REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically and Standard ICU care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qujing Central Hospital of Yunnan Province
Qujing, Yunnan, 655000
chaofu yue, 18313575937, yueaaa0@163.com
About this study
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.
Read the 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.
- Conditions
- ARDS (Acute Respiratory Distress Syndrome), VILI (Ventilator-induced Lung Injury), Respiratory Failure, Critical Illness
- Being tested
- REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically, Standard ICU care
- Medical subject headings
- Acute Lung Injury, Ventilator-Induced Lung Injury, Respiratory Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in criticallyDevice
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..
Standard ICU careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically | Experimental | 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 Receives: Device: REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically |
| Standard ICU care | Active comparator | 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. Receives: Other: Standard ICU care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over the first 72 hours following randomisation
Secondary outcomes (11)
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;
Measured: Day 28 after trial enrollment
ICU length of stay
total number of days from ICU admission to ICU discharge;
Measured: 28 days after ICU admission
Serum concentration of interleukin-1 beta (IL-1β)
Serum IL-1β concentration measured using standardized immunoassays.
Measured: Baseline (within 24hours) and 72 hours after trial enrollment
Serum concentration of interleukin-6 (IL-6)
Serum IL-6 concentration measured using standardized immunoassays.
Measured: 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.
Measured: Baseline (within 24hours) and 72 hours after trial enrollment
Incidence of ventilator-associated pneumonia (VAP)
based on CDC criteria, adjudicated by two independent reviewers;
Measured: 72 hours after trial enrollment
Incidence of barotrauma
including pneumothorax, pneumomediastinum, or subcutaneous emphysema confirmed radiographically
Measured: 72 hours after trial enrollment
ECMO initiation rate
proportion of patients who require extracorporeal support during the index ICU stay;
Measured: 72 hours after trial enrollment
Mortality at day 28
all-cause mortality;
Measured: 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.
Measured: 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.
Measured: 72 hours after trial enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307066
- Sponsor's protocol ID
- K6526
- Acronym
- REALVENT
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 39905371Chen 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.
PubMed 41180101Chen 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.
PubMed 39055813Su 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.
PubMed 36836113Su L, Yang Y, Wang Y, Lan J, Yue C, Yang M, Pensier J, Zhang S, Yang J, Zhang J, Shao H, Wang Y, Zhao J, Song X, Cao H, Wu H, Cai F, Ma Y, Song Z, Talmor D, Baedorf-Kassis E, Long Y. Real-time algorithm-driven ventilation feedback to improve lung-protective ventilation in patients with ARDS (REALVENT-study): study protocol for a multicentre randomised controlled trial. Respir Res. 2026 Jul 4. doi: 10.1186/s12931-026-03766-4. Online ahead of print.
PubMed 42401979
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study)
- ClinicalTrials.gov ID
- NCT07307066
- Acronym / sponsor ID
- REALVENT / K6526
- Conditions
- ARDS (Acute Respiratory Distress Syndrome), VILI (Ventilator-induced Lung Injury), Respiratory Failure, Critical Illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- 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 start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically | Experimental | Device: REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in criticallyPatients 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 comparator | Other: Standard ICU careThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in criticallyPatients 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.. | Device | REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically |
| Standard ICU careThe 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 |
Primary outcome
The daily lung-protective ventilation achievement rate
Time frame: 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
11 secondary outcomes
Ventilator-free days at day 28 (VFD-28)
Time frame: Day 28 after trial enrollment
ICU length of stay
Time frame: 28 days after ICU admission
Serum concentration of interleukin-1 beta (IL-1β)
Time frame: Baseline (within 24hours) and 72 hours after trial enrollment
Serum concentration of interleukin-6 (IL-6)
Time frame: Baseline (within 24hours) and 72 hours after trial enrollment
Serum concentration of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1)
Time frame: Baseline (within 24hours) and 72 hours after trial enrollment
Incidence of ventilator-associated pneumonia (VAP)
Time frame: 72 hours after trial enrollment
Incidence of barotrauma
Time frame: 72 hours after trial enrollment
ECMO initiation rate
Time frame: 72 hours after trial enrollment
Mortality at day 28
Time frame: Day 28 after trial enrollment
Modified NASA Task Load Index (NASA-TLX) score (0-100)
Time frame: 72 hours after trial enrollment
Clinician-reported usability score (mean of 5-item, 5-point Likert scale; range 1-5)
Time frame: 72 hours after trial enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Results publication: PubMed 39905371Liu 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.
- Results publication: PubMed 41180101Chen 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.
- Results publication: PubMed 39055813Chen 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.
- Results publication: PubMed 36836113Su 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.
- Derived from this study: PubMed 42401979Su L, Yang Y, Wang Y, Lan J, Yue C, Yang M, Pensier J, Zhang S, Yang J, Zhang J, Shao H, Wang Y, Zhao J, Song X, Cao H, Wu H, Cai F, Ma Y, Song Z, Talmor D, Baedorf-Kassis E, Long Y. Real-time algorithm-driven ventilation feedback to improve lung-protective ventilation in patients with ARDS (REALVENT-study): study protocol for a multicentre randomised controlled trial. Respir Res. 2026 Jul 4. doi: 10.1186/s12931-026-03766-4. Online ahead of print.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically and Standard ICU care in people with ARDS (Acute Respiratory Distress Syndrome) and VILI (Ventilator-induced Lung Injury), run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longxiang Su, Doctor (+86 15652797257, slx77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The daily lung-protective ventilation achievement rate (time frame: Over the first 72 hours following randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07307066, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.