ARDS, Human
Conditions
Keywords
electrical impedance tomography, ARDS, PEEP
Brief summary
This study is a multicentric randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between EIT-oriented individualized PEEP and traditional lower PEEP/FiO2 table-oriented PEEP strategy.
Interventions
OTHEREIT-guided PEEP
PEEP setting according to EIT
OTHERTable-guided PEEP
PEEP setting according to the lower PEEP/FiO2 table
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor
Exclusion criteria
1. Age \< 18 years old and \> 90 years old; 2. Pregnancy; 3. EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator); 4. Severe intracranial hypertension; 5. Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease); 6. Unstable hemodynamic status intorerable to lung recruitment and PEEP titration, judged by an attending intensivist; (This may be a transient criterion, since patients meeting this criterion might be included later if hemodynamics improves) 7. End status of disease; 8. Patients or their families refused to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival in 28 days | 28 days | Survival within 28 days from randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lenght of ICU stay | Maximum 6-months | Length of hospital stay from randomization to ICU discharge |
| Lenght of hospital stay | Maximum 6-months | Length of hospital stay from randomization to hospital discharge |
| 28-day ventilator-free days | 28 days | Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization. |
| Barotrauma | 7 days | We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele \> 2cm detected on image exams between randomization and 7 days, except those judged to be clearly caused by invasive procedures. |
| ICU survival | Maximum 6-months | Survival at ICU discharge. |
| hospital survival | Maximum 6-months | Survival at hospital discharge. |
| change of Sequential Organ Failure Assessment (SOFA) score | 2 days | change of SOFA score within first 2 days |
Countries
China
Outcome results
None listed