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

NCT07839234 | Enrolling By Invitation

• 1 other identifier: XiamenHTCM
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute respiratory distress syndrome; PiCCO; mechanical power

Outcome Measures

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.

  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.

Study Arms (2)

Prone ventilation group

non-Prone ventilation group

Other: Prone position ventilation

non-Prone ventilation group

non-Prone ventilation

Interventions

Prone position ventilation OTHER

Judgement of Prone Position Therapy Based on Oxygenation Index

Prone ventilation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiamen Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, 361009, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 24, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

CN (1)