Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

Study Overview
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Brief Summary
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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
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Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Official Title
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Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of ARDS Patients

Conditions
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ARDS

Intervention / Treatment
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* Drug: Deep sedated
* Drug: Light sedated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period: Requires positive pressure ventilation through an endotracheal tube Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days 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 No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Self control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline<br>In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated | |
| Experimental: Deep sedation<br>In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously | Drug: Deep sedated<br>* Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)<br>* Other names: Deep sedation;|
| Experimental: Light sedation<br>In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously | Drug: Light sedated<br>* Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)<br>* Other names: Light sedation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transpulmonary pressure generate by patient during deep or light sedation | Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation | 15 minutes during deep or light sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| static compliance of respiratory system | Crs measured during deep or light sedation | 15min during deep or light sedation | 
| PaO2 | ABG after deep or light sedation | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS,, Transpulmonary pressure,, Sedation