Acute respiratory distress syndrome
Conditions
Interventions
Trial group of phenylalanine rimalazolam:Phenylalanine rimalazolam used for sedation
Mitazolam control group:Mitazolam used for sedation
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Admit patients who need ECMO support due to ARDS in the ICU. 2. Diagnostic criteria for ARDS: new or worsening respiratory failure within 7 days that cannot be fully explained by heart failure; chest X-ray or CT showed bilateral exudation or lung ultrasound showed bilateral B-line or consolidation; Patients with HFNO flow rate >=30L/min; For intubated patients, stratified according to SpO2/FiO2, mild (> 235 mmHg and 148 mmHg and =5mmHg. 3. Age >=18 and <=80 years old, gender is not limited. 4. Patients or their families have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Age< 18 years old. 2. Pregnant and lactating women. 3. Those who are allergic to benzodiazepines. 4. Those who have participated in other clinical trials within 30 days before enrollment. 5. Acute severe neurological illness and any other condition that complicates the assessment of RASS scores 6. Any other condition that the treating physician or researcher deems unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients in both groups reaching the target sedation level (RASS score -3 to -2) within the designated time period following drug administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| ECMO duration;ECMO weaning rate;28-day mortality rate;Ventilator-free days at 28 days;ICU length of stay;Hospital length of stay;Heart rate;Systolic blood pressure;Diastolic blood pressure;Mean arterial pressure;Central venous pressure;Complete blood count;Liver and renal function tests ;Coagulation profile;Nausea;Vomiting;Delirium;Autonomous extubation;Total sedation medication costs;Total hospitalization costs; | — |
Countries
China
Contacts
Public ContactXiaoqing Liu
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed