Clinical trial NCT05767125: Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS
Official title: Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS: a Single-center, Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Lung ventilation/perfusion matching
timeFrame: 24hour
Secondary outcomes:
measure: Lung ventilation distrubution
timeFrame: up to 72hour
measure: Lung perfusion distrubution
timeFrame: up to 72hour
measure: Dead-space% and shunting%
timeFrame: up to 72hour
measure: Oxygenation index
timeFrame: up to 72hour
measure: Arterial partial pressure of carbon dioxide (PaCO2)
timeFrame: up to 72hour
measure: Static respiratory compliance (Crs)
timeFrame: up to 72hour
measure: Cardiac output
timeFrame: up to 72hour
measure: Right ventricular function
timeFrame: up to 72hour
measure: Ventilator free days
timeFrame: up to 28days
measure: Duration of Intensive care units stay
timeFrame: up to 28days
measure: Mortality after randomization
timeFrame: up to 28days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: You Shang, prof.
role: PRINCIPAL_INVESTIGATOR
References: