Acute Respiratory Distress Syndrome
Conditions
Brief summary
Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the baby lung from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).
Interventions
DEVICEAPRV
Patients with moderate-to-severe ARDS were supported with APRV.
DEVICELTV
Patients with moderate-to-severe ARDS were supported with LTV.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients aged ≥18 and ≤80 years; 2. Moderate-to-severe ARDS patients according to the Berlin definition; 3. Endotracheal mechanical ventilation ≤48 h before enrollment; 4. Expected to require continuous invasive mechanical ventilation ≥72 h.
Exclusion criteria
1. Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc; 2. Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)； 3. Pulmonary interstitial lesions； 4. End-stage of chronic disease, with an expected survival period of \<6 months； 5. Body mass index \>35 kg/m2; 6. Refractory shock； 7. Intracranial hypertension； 8. Pregnant and parturient woman； 9. Intra-abdominal pressure persisted \> 20 mmHg and could not be relieved within 24 hours； 10. Severe thoracic deformity； 11. Severe cardiac dysfunction； 12. Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output； 13. Pulmonary embolism； 14. Extracorporeal membrane oxygenation is needed； 15. Prone positioning was performed before randomization； 16. Patients who have participated in other clinical trials within 30 days； 17. Patients who have not signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung ventilation/perfusion matching | 24hour | Lung ventilation/perfusion matching assessed by EIT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung perfusion distrubution | up to 72hour | Lung perfusion distrubution assessed by EIT |
| Dead-space% and shunting% | up to 72hour | Lung Dead-space% and shunting% assessed by EIT |
| Oxygenation index | up to 72hour | Oxygenation index=Arterial partial pressure of oxygen /fraction of inspired oxygen |
| Arterial partial pressure of carbon dioxide (PaCO2) | up to 72hour | PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis. |
| Static respiratory compliance (Crs) | up to 72hour | Crs=tidal volume/driving pressure |
| Lung ventilation distrubution | up to 72hour | Lung ventilation distrubution assessed by EIT |
| Right ventricular function | up to 72hour | Right ventricular function assessed by echocardiography |
| Ventilator free days | up to 28days | 28d-ventilator free days after randomization |
| Duration of Intensive care units stay | up to 28days | 28d-duration of Intensive care units stay after randomization |
| Mortality after randomization | up to 28days | 28d-all-cause mortality |
| Cardiac output | up to 72hour | Cardiac output assessed by echocardiography |
Countries
China
Contacts
Primary ContactXiaojing Zou, prof.
Backup ContactYou Shang, prof.
Outcome results
None listed