ClinicalTrials.gg
Enrolling by invitationNCT07839234Updated Sep 24, 2026

Application Study of Individualized Mechanical Power Titration Strategy Based on PiCCO (Pulse Index Continuous Cardiac Output) Monitoring Parameters in ARDS Patients

An observational study in Acute Respiratory Distress Syndrome, sponsored by Xiamen Hospital of Traditional Chinese Medicine. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Xiamen Hospital of Traditional Chinese Medicine · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 146 studies in Respiratory Distress Syndrome with a site in China — 54 open to participants now, 55 under way, 6 of them phase 3. Respiratory Distress Syndrome · China.

Planned enrollment
35th of 65
130 · median 139
Started
2025
with 12 others
Observational
65 of 146
22 open now
Primary completion
2028-09
later than 49 of 54 live
Registered
142nd of 146
by date

Among the 146 studies in Respiratory Distress Syndrome with a site in China, this one is the 35th largest by planned enrollment of the 65 observational ones that give a count, is one of 13 that started in 2025, is one of 65 observational ones, reaches primary completion later than 49 of the 54 other live ones, and was the 142nd registered.

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 282 are open to participants now.

Browse Respiratory Distress Syndrome studies →

Open to participants now

54 of the 146 studies in Respiratory Distress Syndrome with a site in China are open now. Recruiting first, the newest first:

49 more — sign in →

All 54 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 193 Respiratory Distress Syndrome studies recruiting now, 117 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 50 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Acute Respiratory Distress Syndrome

Keywords

  • Acute respiratory distress syndrome
  • PiCCO
  • mechanical power
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form (if the patient has consciousness disorders, it can be signed by a legal representative)

Exclusion criteria

Exclusion criteria :

  • There are for PiCCO monitoring
  • Pregnant or lactating women
  • Recently (within one month) participated in other interventional clinical studies
  • Expected death within 48 hours
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No

Groups and cohorts

  • Prone ventilation group

    non-Prone ventilation group

    Other: Prone position ventilation

  • non-Prone ventilation group

    non-Prone ventilation

Interventions

  • OtherProne position ventilation

    Judgement of Prone Position Therapy Based on Oxygenation Index

06

What researchers measure

Primary outcomes

  1. 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.

    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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Informed consent form

Time frame: The IPD and supporting information will be available starting from 1 December 2028 to 31 December 2029.

Access criteria: Access is limited to qualified non-commercial academic researchers. Approved users can obtain anonymized IPD and full trial supporting documents including analysis reports. Applicants shall submit a research application for committee review first, and then get secure platform access upon approval.

Data sharing details ↗ · clinicaltrials.gov

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Sep 2028, 34 months after the start.

Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 34 months is above that.

Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Sep 24, 2026
StartActual
Nov 4, 2025
Primary completionEst.
Sep 30, 2028
CompletionEst.
Sep 30, 2028
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07839234
Lead sponsor
Xiamen Hospital of Traditional Chinese Medicine
Responsible party
Xu Hao (Head of Department, Xiamen Hospital of Traditional Chinese Medicine) — Principal investigator
First posted
Sep 24, 2026
Start date
Nov 4, 2025
Primary completion
Sep 30, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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