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

NCT06808438 | Completed

• 2 other identifiers: PEEP Titration2022YFC2504403
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• the value of set PEEP

  Select the optimal PEEP value according to different ways

  through study completion, an average of 1 year

Interventions

Esophageal pressure catheter DEVICE

Esophageal pressure was monitored with an esophageal pressure catheter

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

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University, Chengdu

Chengdu, Sichuan, 610041, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief respiratory therapist

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: February 5, 2025
• Study Start: October 1, 2022
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: February 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)