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

NCT ID: NCT06808438

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-07-20

Brief Summary

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.

Conditions

ARDS

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Esophageal pressure catheter

Esophageal pressure was monitored with an esophageal pressure catheter

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Yongfang

Chief respiratory therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital of Sichuan University, Chengdu

Chengdu, Sichuan, China

Countries

China

Other Identifiers

2022YFC2504403

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PEEP Titration

Identifier Type: -

Identifier Source: org_study_id