ARDS
Conditions
Keywords
ARDS,, Transpulmonary pressure,, Sedation
Brief summary
The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near diaphram during mechanical ventilation, however, strong respiratory drive could generate more transpulmonary pressure in ARDS patients, which increase the stress and strain in injured lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of ARDS patients.The purpose of this study is to investigate the effects of sedation on transpulmonary pressure of ARDS patients.
Detailed description
Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University
Interventions
DRUGDeep sedated
Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)
DRUGLight sedated
Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Masking description
No Masking
Intervention model description
Self control
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period: 1. Requires positive pressure ventilation through an endotracheal tube 2. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days 3. PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP) at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7 days 4. No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine \<10ug/kg•min or norepinephrine \<10ug/kg) 2. Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine \<10ug/kg•min or norepinephrine \<10ug/kg)
Exclusion criteria
* Age younger than 18 years or older than 85 years * Cardiac failure * Known pregnancy * Increased intracranial pressure * Severe neuromuscular disease * Recent injury or other pathologic condition of the esophagus * Pneumothorax * Pleural effusion * Diaphragmatic hernia * Severe chronic respiratory disease * End-stage chronic organ failure * Expected survival of less than 24 hours * Participation in another interventional study * Attending physician declines to give consent for participant to enroll * Patient or surrogate declines or is unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transpulmonary pressure generate by patient during deep or light sedation | 15 minutes during deep or light sedation | Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| static compliance of respiratory system | 15min during deep or light sedation | Crs measured during deep or light sedation |
| PaO2 | 15 minutes | ABG after deep or light sedation |
Other
| Measure | Time frame | Description |
|---|---|---|
| MAP | 15 minutes | MAP during deep or light sedation |
Countries
China
Outcome results
None listed