Effects of Sedation on Transpulmonary Pressure and Lung Homogenous (ARDS)

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

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.

Study Overview

• Status: Completed
• Conditions: ARDS
• Intervention / Treatment: Drug: Deep sedated; Drug: Light sedated

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAP	MAP during deep or light sedation	15 minutes

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Songqiao Liu, Doctor, Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2015
• Primary Completion (Actual): January 18, 2018
• Study Completion (Actual): March 18, 2018

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: July 30, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 18, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Sedation; ARDS,; Transpulmonary pressure,
• Other Study ID Numbers: 2012ZDIIKY22.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No