Status:
COMPLETED
Effect of EIT-guided PEEP Titration on the Prognosis of Patients with Moderate to Severe ARDS
Lead Sponsor:
Southeast University, China
Conditions:
Clinical Outcomes
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lu...
Detailed Description
This is a prospective, multicenter, single-blind, parallel-group, adaptive randomized controlled trial (RCT) with intention-to-treat analysis which aims to determine the effects of PEEP setting guided...
Eligibility Criteria
Inclusion
- Age≥18 years
- Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen \[PaO2\]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O)
- Diagnosis of ARDS less than 72 hours
Exclusion
- Expected to be mechanically ventilated for less than 48 hours
- Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV
- Undrained pneumothorax or subcutaneous emphysema
- Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment
- Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
- Severe neuromuscular disease
- Hemodynamic instability
- Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome
- Severe other organs dysfunction with a low expected survival (7 days) or palliative care
- Solid organ or hematologic tumors with the expected survival time less than 30 days
- Participating in other clinical trials within 30 days
- Pregnancy
- Refusal to sign the informed consent
Key Trial Info
Start Date :
February 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2023
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05207202
Start Date
February 20 2022
End Date
July 20 2023
Last Update
March 20 2025
Active Locations (5)
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1
the First Affiliated Hospital of Guangzhou Medical University, Department of Critical Care Medicine
Guangzhou, Guangdong, China, sonysang999@aliyun.com
2
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, China, 210000
3
Department of Critical Care Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 200120
4
Department of Critical Care Medicine, Zhongshan Hospital of Fudan University
Shangha, Shangha, China, 200032