Acute Respiratory Distress SyndromeNCT07839234
Application Study of Individualized Mechanical Power Titration Strategy Based on PiCCO (Pulse Index Continuous Cardiac Output) Monitoring Parameters in ARDS Patients
An observational study of Acute Respiratory Distress Syndrome, run by Xiamen Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Based on PiCCO combined with MP, the optimal mechanical power setting of the ventilator for ARDS patients in normal supine/prone position is determined to reduce the damage to lung function during mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Prone position ventilation
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2025to 30 Sep 2028
- Phase
- Observational
- 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
Study population: The research plan includes 130 patients. Divide into two groups, with 65 cases in each group. A: ARDS patients who use conventional ventilation during mechanical ventilation; B: ARDS patients who use prone position ventilation during mechanical ventilation.
Who may be able to join
- Admission to ICU
- Accept mechanical ventilation, with an expected duration of more than 3 days
- Diagnose 'ARDS' and meet the criteria for mild, moderate, and severe diagnosis
- Age over 18 years old
- Voluntarily participate in the study and sign an informed consent form (if the patient has consciousness disorders, it can be signed by a legal representative)
Who cannot join
- There are contraindications for PiCCO monitoring
- Pregnant or lactating women
- Recently (within one month) participated in other interventional clinical studies
- Expected death within 48 hours
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
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, 361009
About this study
Based on PiCCO combined with MP, the optimal mechanical power setting of the ventilator for ARDS patients in normal supine/prone position is determined to reduce the damage to lung function during mechanical ventilation. By detecting peripheral serum NLRP3 and related inflammatory markers in ARDS patients, the relationship between NLRP3 and lung injury caused by mechanical ventilation was studied.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Prone position ventilation
- Keywords
- Acute respiratory distress syndrome, PiCCO, mechanical power
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone position ventilationOther
Judgement of Prone Position Therapy Based on Oxygenation Index
| Study group | Role | What they receive |
|---|---|---|
| Prone ventilation group | non-Prone ventilation group Receives: Other: Prone position ventilation | |
| non-Prone ventilation group | non-Prone ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical power
deep sedation, elimination of spontaneous breathing, measurement via ventilator.Mechanical power (MP) was calculated from the median ventilator parameters via the following equation: mechanical power (J/min) = 0.098× RR × Vt × (PIP - 0.5(Pplateau-PEEP)), where PIP =peak inspiratory pressure. The MP was normalized to the predicted body weight (norMP) = MP/PBW,where PBW was the predicted body weight measured in kilograms.
Measured: Data were obtained within the first hour post-intubation, at 8:00 AM (±1 h) daily for the subsequent three consecutive days, and during position changes (prone to supine or supine to prone) within these three days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start4 Nov 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Hao, Xiamen Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839234
- Sponsor's protocol ID
- XiamenHTCM
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No raw individual-level participant data will be publicly shared. Upon reasonable scientific request and after signing a data-use agreement, de-identified aggregated clinical data may be provided. No identifiable personal information including names, ID numbers, addresses or contact information will be released.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Study of Individualized Mechanical Power Titration Strategy Based on PiCCO (Pulse Index Continuous Cardiac Output) Monitoring Parameters in ARDS Patients
- ClinicalTrials.gov ID
- NCT07839234
- Acronym / sponsor ID
- XiamenHTCM
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, PiCCO, mechanical power
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Xiamen Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 24 Sep 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.
Based on PiCCO combined with MP, the optimal mechanical power setting of the ventilator for ARDS patients in normal supine/prone position is determined to reduce the damage to lung function during mechanical ventilation. By detecting peripheral serum NLRP3 and related inflammatory markers in ARDS patients, the relationship between NLRP3 and lung injury caused by mechanical ventilation was studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone ventilation group | – | Other: Prone position ventilationnon-Prone ventilation group |
| non-Prone ventilation group | – | –non-Prone ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research plan includes 130 patients. Divide into two groups, with 65 cases in each group. A: ARDS patients who use conventional ventilation during mechanical ventilation; B: ARDS patients who use prone position ventilation during mechanical ventilation.
Key inclusion criteria (5 listed)
- Admission to ICU
- Accept mechanical ventilation, with an expected duration of more than 3 days
- Diagnose 'ARDS' and meet the criteria for mild, moderate, and severe diagnosis
- Age over 18 years old
- Voluntarily participate in the study and sign an informed consent form (if the patient has consciousness disorders, it can be signed by a legal representative)
Key exclusion criteria (4 listed)
- There are contraindications for PiCCO monitoring
- Pregnant or lactating women
- Recently (within one month) participated in other interventional clinical studies
- Expected death within 48 hours
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 |
|---|---|---|
| Prone position ventilationJudgement of Prone Position Therapy Based on Oxygenation Index | Other | Prone ventilation group |
Primary outcome
mechanical power
Time frame: Data were obtained within the first hour post-intubation, at 8:00 AM (±1 h) daily for the subsequent three consecutive days, and during position changes (prone to supine or supine to prone) within these three days.
deep sedation, elimination of spontaneous breathing, measurement via ventilator.Mechanical power (MP) was calculated from the median ventilator parameters via the following equation: mechanical power (J/min) = 0.098× RR × Vt × (PIP - 0.5(Pplateau-PEEP)), where PIP =peak inspiratory pressure. The MP was normalized to the predicted body weight (norMP) = MP/PBW,where PBW was the predicted body weight measured in kilograms.
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes. No raw individual-level participant data will be publicly shared. Upon reasonable scientific request and after signing a data-use agreement, de-identified aggregated clinical data may be provided. No identifiable personal information including names, ID numbers, addresses or contact information will be released.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Xiamen Hospital of Traditional Chinese Medicine 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 4 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: enrolling by invitation, as of the sponsor's last update on 24 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical power (time frame: Data were obtained within the first hour post-intubation, at 8:00 AM (±1 h) daily for the subsequent three consecutive days, and during position changes (prone to supine or supine to prone) within these three 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 24 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.