ARDS (Moderate or Severe)NCT07490925
Transpulmonary Pressure-guided Mechanical Ventilation Strategy in Right Ventricular Protection in Patients With ARDS
A study testing Transpulmonary pressure guided mechanical ventilation strategy in people with ARDS (Moderate or Severe), run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
To verify whether the transpulmonary pressure-guided mechanical ventilation strategy can reduce right ventricular involvement, especially the incidence of acute cor pulmonale (ACP), in patients with moderate to severe ARDS induced by pneumonia compared with the currently widely used right ventricular protective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Moderate or Severe)
- What is being tested?
- Transpulmonary pressure guided mechanical ventilation strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2026to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- ARDS caused by pneumonia (New Global Definition of ARDS)
- PaO2/FiO2≤200mmHg
- Received invasive mechanical ventilation
- Sign the informed consent form
Who cannot join
- Invasive mechanical ventilation duration > 48 hours
- History of pulmonary hypertension caused by various reasons
- Severe arrhythmia
- BMI>30kg/m2
- Contraindications to inserting an esophageal catheter (including recent esophageal injury or surgery, severe coagulopathy (platelets < 5×10⁹/L or INR > 4)
- Pregnant and lactating women
Show all 13Show fewer
- Lung transplant recipient
- High-risk factors for increased intracranial pressure (including intracranial hemorrhage, cerebral contusion, cerebral edema, intracranial space-occupying lesions, etc.)
- Active air leakage in the lungs (pneumothorax, mediastinal emphysema, bronchopleural fistula, air leakage from closed thoracic drainage tubes, etc.)
- Neuromuscular disease
- Already received salvage measures (iNO, ECMO, prone position, high-frequency oscillatory ventilation)
- Severe liver failure
- Participated in other ARDS-related studies within 30 days
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
Beijing Chao-Yang Hospital
Beijing
Xiao Tang, 86013811089795, tangxiao0928@163.com
About this study
Official title: Application of Transpulmonary Pressure-guided Mechanical Ventilation Strategy in Right Ventricular Protection in Patients With Acute Respiratory Distress Syndrome Caused by Pneumonia
To verify whether the transpulmonary pressure-guided mechanical ventilation strategy can reduce right ventricular involvement, especially the incidence of acute cor pulmonale (ACP), in patients with moderate to severe ARDS induced by pneumonia compared with the currently widely used right ventricular protective mechanical ventilation strategy.
- Conditions
- ARDS (Moderate or Severe)
- Being tested
- Transpulmonary pressure guided mechanical ventilation strategy
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpulmonary pressure guided mechanical ventilation strategyDevice
Tidal volume is adjusted to achieve a target tidal volume of 6 mL/kg predicted body weight (PBW) while controlling end-inspiratory transpulmonary pressure ≤ 20 cmH₂O. PEEP is adjusted to maintain end-expiratory transpulmonary pressure between 0 and 2 cmH₂O.
In control group, PEEP was titrated using the low PEEP:FiO₂ table method.
| Study group | Role | What they receive |
|---|---|---|
| Transpulmonary pressure group | Experimental | The overall concept of this group is to individualize PEEP. After enrollment, all patients underwent placement of an gastric tube for esophageal pressure monitoring.Tidal volume is adjusted to achieve a target tidal volume of 6 mL/kg predicted body weight (PBW) while controlling end-inspiratory transpulmonary pressure ≤ 20 cmH₂O. PEEP is adjusted to maintain end-expiratory transpulmonary pressure between 0 and 2 cmH₂O. FiO₂ is titrated to keep the patient's SpO₂ at 90%-95%. Respiratory rate is adjusted to maintain pH between 7.30 and 7.45 and PaCO₂ ≤ 60 mmHg.
If end-inspiratory transpulmonary pressure exceeds 20 cmH₂O, tidal volume may be reduced to 4 mL/kg PBW as necessary. For patients with severe dyspnea or respiratory acidosis, tidal volume may be increased up to 8 mL/kg PBW provided that end-inspiratory transpulmonary pressure remains ≤ 20 cmH₂O. Receives: Device: Transpulmonary pressure guided mechanical ventilation strategy |
| Control group | No intervention | In this group, PEEP was titrated using the low PEEP:FiO₂ table method. Volume-assist control (V-A/C) ventilation was adopted, with tidal volume maintained at approximately 6 mL/kg predicted body weight (PBW) and plateau pressure controlled at ≤ 30 cmH₂O. PEEP was adjusted to maintain the oxygenation target of SpO₂ 90%-95% while using the lowest possible PEEP:FiO₂ combination in the table. Respiratory rate was adjusted to maintain pH between 7.30 and 7.45 and PaCO₂ ≤ 60 mmHg. Esophageal pressure monitoring was simultaneously performed in this group to calculate and record end-inspiratory and end-expiratory transpulmonary pressures; however, ventilator parameters were not adjusted based on these measurements, and crossover to the transpulmonary pressure (Ptp) group was not permitted. If plateau pressure exceeded 30 cmH₂O, tidal volume could be reduced to 4 mL/kg PBW as necessary. For patients with severe dyspnea or respiratory acidosis, tidal volume could be increased up to 8 mL/kg PBW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of right ventricular involvement within 28 days
Right ventricular involvement is defined as the presence of one of the following findings on transthoracic echocardiography:
ACP: Right ventricular enlargement (RVED/LVED > 0.6) with paradoxical septal motion; RVF: Right ventricular enlargement (RVED/LVED > 0.6) accompanied by systemic venous congestion (CVP ≥ 8 mmHg), or if CVP is unavailable, inferior vena cava plethora; RVD: RV FAC < 35%, or TAPSE ≤ 16 mm.
Measured: 28 days
Secondary outcomes (4)
The respective incidence rates of ACP, RVF and RVD
Measured: 28 days
ICU mortality
Measured: 28 days and 60 days
invasive mechanical ventilation duration
Measured: 28 days
the number of participants receiving vasoactive agents
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start23 Mar 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Moderate or Severe)Studies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490925
- Sponsor's protocol ID
- CYTS2025B20
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transpulmonary Pressure-guided Mechanical Ventilation Strategy in Right Ventricular Protection in Patients With Acute Respiratory Distress Syndrome Caused by Pneumonia
- ClinicalTrials.gov ID
- NCT07490925
- Acronym / sponsor ID
- CYTS2025B20
- Conditions
- ARDS (Moderate or Severe)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
To verify whether the transpulmonary pressure-guided mechanical ventilation strategy can reduce right ventricular involvement, especially the incidence of acute cor pulmonale (ACP), in patients with moderate to severe ARDS induced by pneumonia compared with the currently widely used right ventricular protective mechanical ventilation strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpulmonary pressure group | Experimental | Device: Transpulmonary pressure guided mechanical ventilation strategyThe overall concept of this group is to individualize PEEP. After enrollment, all patients underwent placement of an gastric tube for esophageal pressure monitoring.Tidal volume is adjusted to achieve a target tidal volume of 6 mL/kg predicted body weight (PBW) while controlling end-inspiratory transpulmonary pressure ≤ 20 cmH₂O. PEEP is adjusted to maintain end-expiratory transpulmonary pressure between 0 and 2 cmH₂O. FiO₂ is titrated to keep the patient's SpO₂ at 90%-95%. Respiratory rate is adjusted to maintain pH between 7.30 and 7.45 and PaCO₂ ≤ 60 mmHg. If end-inspiratory transpulmonary pressure exceeds 20 cmH₂O, tidal volume may be reduced to 4 mL/kg PBW as necessary. For patients with severe dyspnea or respiratory acidosis, tidal volume may be increased up to 8 mL/kg PBW provided that end-inspiratory transpulmonary pressure remains ≤ 20 cmH₂O. |
| Control group | No intervention | –In this group, PEEP was titrated using the low PEEP:FiO₂ table method. Volume-assist control (V-A/C) ventilation was adopted, with tidal volume maintained at approximately 6 mL/kg predicted body weight (PBW) and plateau pressure controlled at ≤ 30 cmH₂O. PEEP was adjusted to maintain the oxygenation target of SpO₂ 90%-95% while using the lowest possible PEEP:FiO₂ combination in the table. Respiratory rate was adjusted to maintain pH between 7.30 and 7.45 and PaCO₂ ≤ 60 mmHg. Esophageal pressure monitoring was simultaneously performed in this group to calculate and record end-inspiratory and end-expiratory transpulmonary pressures; however, ventilator parameters were not adjusted based on these measurements, and crossover to the transpulmonary pressure (Ptp) group was not permitted. If plateau pressure exceeded 30 cmH₂O, tidal volume could be reduced to 4 mL/kg PBW as necessary. For patients with severe dyspnea or respiratory acidosis, tidal volume could be increased up to 8 mL/kg PBW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- ARDS caused by pneumonia (New Global Definition of ARDS)
- PaO2/FiO2≤200mmHg
- Received invasive mechanical ventilation
- Sign the informed consent form
Key exclusion criteria (13 listed)
- Invasive mechanical ventilation duration > 48 hours
- History of pulmonary hypertension caused by various reasons
- Severe arrhythmia
- BMI>30kg/m2
- Contraindications to inserting an esophageal catheter (including recent esophageal injury or surgery, severe coagulopathy (platelets < 5×10⁹/L or INR > 4)
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 |
|---|---|---|
| Transpulmonary pressure guided mechanical ventilation strategyTidal volume is adjusted to achieve a target tidal volume of 6 mL/kg predicted body weight (PBW) while controlling end-inspiratory transpulmonary pressure ≤ 20 cmH₂O. PEEP is adjusted to maintain end-expiratory transpulmonary pressure between 0 and 2 cmH₂O. In control group, PEEP was titrated using the low PEEP:FiO₂ table method. | Device | Transpulmonary pressure group |
Primary outcome
Incidence of right ventricular involvement within 28 days
Time frame: 28 days
Right ventricular involvement is defined as the presence of one of the following findings on transthoracic echocardiography: ACP: Right ventricular enlargement (RVED/LVED > 0.6) with paradoxical septal motion; RVF: Right ventricular enlargement (RVED/LVED > 0.6) accompanied by systemic venous congestion (CVP ≥ 8 mmHg), or if CVP is unavailable, inferior vena cava plethora; RVD: RV FAC < 35%, or TAPSE ≤ 16 mm.
4 secondary outcomes
The respective incidence rates of ACP, RVF and RVD
Time frame: 28 days
ICU mortality
Time frame: 28 days and 60 days
invasive mechanical ventilation duration
Time frame: 28 days
the number of participants receiving vasoactive agents
Time frame: 28 days
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 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 Transpulmonary pressure guided mechanical ventilation strategy in people with ARDS (Moderate or Severe), run by Beijing Chao Yang 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 5 inclusion and 13 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 14 Sep 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 Xiao Tang, MD (86013811089795, tangxiao0928@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of right ventricular involvement within 28 days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.