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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

    The principal endpoint was the set of 15 method-specific selected PEEP values(cmH2O)

Secondary outcomes

  1. the variables measured at each selected PEEP

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

    Secondary physiological endpoints were the variables measured at each selected PEEP: SpO₂/FiO₂, Crs(cmH2O), plateau pressure(cmH2O), driving pressure(cmH2O), end-inspiratory and end-expiratory transpulmonary pressure(cmH2O), transpulmonary driving pressure(cmH2O), mechanical power(J/min), heart rate(beats/min), mean arterial pressure(cmH2O), and EIT-derived regional indices, EIT data were continuously acquired and analyzed offline to quantify regional tidal ventilation, center of ventilation, global inhomogeneity, and compliance loss at high and low PEEP, interpreted as overdistension and collapse, respectively.

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
2023
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2025
Registry last updated
Jul 6, 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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