Clinical trial NCT03237806: Effects of Sedation on Transpulmonary Pressure and Lung Homogenous
Official title: Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of ARDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Keywords: ARDS,
Transpulmonary pressure,
Sedation
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Self control
Primary purpose: SCREENING

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

Eligibility criteria: 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

Primary outcomes:
measure: Transpulmonary pressure generate by patient during deep or light sedation
timeFrame: 15 minutes during deep or light sedation
Secondary outcomes:
measure: static compliance of respiratory system
timeFrame: 15min during deep or light sedation
measure: PaO2
timeFrame: 15 minutes
Other outcomes:
measure: MAP
timeFrame: 15 minutes
Locations:
city: Nanjing
country: China
facility: Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University
state: Jiangsu
Study officials:
affiliation: Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University
name: Songqiao Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: