Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

Not Applicable

Completed

• Conditions: ARDS
• Interventions: Drug: Deep sedated; Drug: Light sedated

• Registration Number: NCT03237806
• Lead Sponsor: Southeast University, China

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

Study Timeline

• Study First Submitted: 2014-05-21
• Study Start: 2015-05-31
• Study First Submitted QC: 2017-07-30
• Study First Posted: 2017-08-03
• Primary Completion: 2018-01-18
• Status Verified: 2018-03
• Study Completion: 2018-03-18
• Last Update Submitted: 2018-03-18
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Deep sedation	Deep sedated	In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously
Light sedation	Light sedated	In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PaO2	15 minutes	ABG after deep or light sedation
static compliance of respiratory system	15min during deep or light sedation	Crs measured during deep or light sedation

Trial Locations

Locations (1)

Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University; 🇨🇳 Nanjing, Jiangsu, China