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Completed

NCT Number: NCT06808438

Incremental and Decremental PEEP Titration by Diverse Strategies in Subjects With ARDS: A Prospective Physiological Study

The investigators conducted a prospective physiological observation study on ARDS population, described their physiological and EIT indexes with various PEEP titration methods, and also compared and analyzed those indexes to determine whether there were differences among various PEEP titration methods.The objective of this study was to explore and uncover the physiological differences in response to optimal PEEP in different ways,and analyzed the correlation of the optimal PEEP in these different ways.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital of Sichuan University, Chengdu

Chengdu, Sichuan, 610041, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intubated and mechanical ventilated patients in ICU within 48 hours
  • Be over 18 years old
  • With moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg)

Exclusion criteria

  • Severe chronic obstructive pulmonary diseases
  • Pulmonary bulla(>1CM) or pneumothorax or pneumomediastinum or subcutaneous emphysema
  • Pregnancy
  • BMI≥35kg/m2
  • Suspected pulmonary vascular hemorrhage
  • Disturbance of consciousness or intracranial hypertension
  • Severe cardiac dysfunction (New York Heart Association Class III or IV, acute -Coronary syndrome or persistent ventricular tachyarrhythmia), cardiogenic shock or after major cardiac surgery
  • Hemodynamic instability (i.e., mean arterial pressure [MAP]<60 mm Hg despite vasopressor use
  • The medical team considering short periods of high pressure to be unsafe
  • Contraindications for placement of esophageal pressure catheters (e.g., esophageal varix or fracture of skull base)
  • Contraindications for EIT monitoring (including pacemaker, or cutaneous diseases which limiting electrode placement)
  • Agonal stage or end-stages of diseases

Treatment and study plan

Esophageal pressure catheter

Device

Esophageal pressure was monitored with an esophageal pressure catheter

Primary outcomes

  1. the selected PEEP values

    Time frame: through study completion, an average of 1 year

    • Method-specific selected PEEP values
    • Description: The principal endpoint was the set of 15 method-specific selected PEEP values determined for each patient.
    • Unit of Measure: cmH₂O

Secondary outcomes

  1. SpO2/FiO2 at each selected PEEP

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    SpO2/FiO2 measured at each selected PEEP. This study will separately measure peripheral oxygen saturation (SpO₂, unit: %) and fraction of inspired oxygen (FiO₂, unit: %). Because both measurements share the same unit (%), they will not be reported as separate outcome measures. Instead, they will be aggregated into a single reported value: the SpO₂/FiO₂ ratio (dimensionless). At each selected positive end-expiratory pressure (PEEP) level, the ratio will be calculated as S/F = SpO₂ (%) ÷ FiO₂ (%), and this ratio will be recorded as the final outcome measure.

  2. respiratory system compliance value at each selected PEEP

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    This study will directly record the respiratory system compliance value as measured and displayed by the ventilator (unit: mL/cmH₂O) at each selected PEEP.

  3. plateau pressure at each selected PEEP

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    At each selected positive end-expiratory pressure (PEEP) level, plateau pressure will be directly recorded from the ventilator after performing an inspiratory hold maneuver. This value is displayed by the ventilator in cmH₂O

  4. Driving Pressure at each selected PEEP

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    At each selected positive end-expiratory pressure (PEEP) level, plateau pressure (Pplat, unit: cmH₂O) will be measured via the ventilator, and the corresponding PEEP value (unit: cmH₂O) will be recorded. Driving pressure (ΔP) is calculated as the difference between the two: ΔP = Pplat - PEEP (unit: cmH₂O).

  5. End-inspiratory Transpulmonary Pressure (PTPi) at each selected PEEP

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-inspiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPi) is calculated as the difference between the airway plateau pressure (Pplat) measured during the hold and the corresponding esophageal pressure (Pes): PTPi = Pplat - Pes (unit: cmH₂O).

  6. End-expiratory Transpulmonary Pressure (PTPe) at each selected PEEP

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-expiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPe) is calculated as the difference between the PEEP measured during the hold and the corresponding esophageal pressure (Pes): PTPe = PEEP - Pes (unit: cmH₂O). This calculated value is the single reported outcome measure

  7. transpulmonary driving pressure at each selected PEEP

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    After placement of an esophageal pressure catheter, the ventilator will monitor transpulmonary pressures. At each selected PEEP level, end-inspiratory transpulmonary pressure (PTPi) and end-expiratory transpulmonary pressure (PTPe) are obtained during inspiratory and expiratory hold maneuvers, respectively. Both are measured in cmH₂O. Transpulmonary driving pressure is calculated as the difference: ΔPtp = PTPi - PTPe (unit: cmH₂O).

  8. EIT-derived Regional Ventilation Parameters at each selected PEEP level

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    Using electrical impedance tomography (EIT), the lung is divided into four regions of interest (ROI I to ROI IV) from ventral to dorsal. For each ROI, the percentage of tidal impedance variation relative to total tidal impedance variation is recorded (% of total). unit: cmH₂O

  9. the center of ventilation (COV) at each selected PEEP level

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    the center of ventilation (COV) is calculated as the position of the ventilation center along the ventral-dorsal axis, expressed as a percentage (0% = ventral, 100% = dorsal). this parameter is measured in %

  10. CL HP% (overdistension region) at each selected PEEP level

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    Using electrical impedance tomography (EIT),based on regional compliance analysis,CL HP% represent the percentage of lung regions showing a decrease in compliance at high PEEP due to overdistension (unit: %).

  11. CL LP% (collapse region) at selected PEEP

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

    Using electrical impedance tomography (EIT),based on regional compliance analysis,CL LP% represent the percentage of lung regions showing a decrease in compliance at low PEEP due to collapse (unit: %).

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Research on Precision Individualized Mechanical Ventilation Strategies for ARDS Guided by Electrical Impedance Tomography Monitoring and Evaluation of the Differences in Ventilation and Perfusion Distribution

Acronym: ARDS,PEEP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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