Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

ARDS Clinical Trial

— ARDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237806
• Other study ID #: 2012ZDIIKY22.0
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: March 18, 2018
• Start date: May 31, 2015
• Est. completion date: March 18, 2018

Study information

• Verified date: March 2018
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 18, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS

Intervention

Drug:
• Deep sedated
Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)
• Light sedated
Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MAP	MAP during deep or light sedation	15 minutes
Primary	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	static compliance of respiratory system	Crs measured during deep or light sedation	15min during deep or light sedation
Secondary	PaO2	ABG after deep or light sedation	15 minutes