Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

NCT ID: NCT03237806

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-03-18

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

Conditions

ARDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Baseline

In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Deep sedation

In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously

Group Type: EXPERIMENTAL

Deep sedated

Intervention Type: DRUG

Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)

Light sedation

In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously

Group Type: EXPERIMENTAL

Light sedated

Intervention Type: DRUG

Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)

Interventions

Deep sedated

Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)

Intervention Type: DRUG

Light sedated

Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)

Intervention Type: DRUG

Other Intervention Names

Deep sedation; Light sedation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Songqiao Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Songqiao Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Locations

Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2012ZDIIKY22.0

Identifier Type: -

Identifier Source: org_study_id