Incremental and Decremental PEEP Titration by Diverse Strategies in Subjects with ARDS: a Prospective Physiological Study (ARDS，PEEP)

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

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.

Study Overview

• Status: Completed
• Conditions: ARDS
• Intervention / Treatment: Device: Esophageal pressure catheter

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University, Chengdu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ntubated and mechanical ventilated patients over 18 years with moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg) admitted to the ICU within 48 hours were enrolled from October 2022 to July 2024.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the value of set PEEP	Select the optimal PEEP value according to different ways	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): July 20, 2024
• Study Completion (Actual): July 20, 2024

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Peep Titration; 2022YFC2504403 (Other Grant/Funding Number: National Key R＆D Program of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No