Effect of EIT-guided PEEP in ARDS Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-90
SponsorSoutheast University, China
About this trial
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 lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. Our previous study found that moderate to severe ARDS patients with higher recruitability could benefit from EIT-guided PEEP. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes in ARDS patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
Trial design
Design model
Parallel
Treatments tested in this trial
EIT-guided PEEP
DevicePEEP titrated by EIT will be performed with a decremental trial at the enrollment. Right after completing RM, PEEP will be set to 20cmH2O or to 24cmH2O and then reduced in steps of 2cmH2O from 20 to 4 every 30s.
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: EIT-guided PEEP groupExperimental treatment 1 intervention
Group B: low PEEP-FiO2 table groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
28-day mortality
Time frame
mortality in Day 28Sponsors and contacts
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Source ClinicalTrials.gov