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ARDS: Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

Sponsor
Southeast University, China (Other)
Overall Status
Completed
CT.gov ID
NCT03237806
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
33.6
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Deep sedated
  • Drug: Light sedated
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Self controlSelf control
Masking:
None (Open Label)
Masking Description:
No Masking
Primary Purpose:
Screening
Official Title:
Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of ARDS Patients
Actual Study Start Date :
May 31, 2015
Actual Primary Completion Date :
Jan 18, 2018
Actual Study Completion Date :
Mar 18, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. static compliance of respiratory system [15min during deep or light sedation]

      Crs measured during deep or light sedation

    2. PaO2 [15 minutes]

      ABG after deep or light sedation

    Other Outcome Measures

    1. MAP [15 minutes]

      MAP during deep or light sedation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:

    2. Requires positive pressure ventilation through an endotracheal tube

    3. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days

    4. 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

    5. No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine <10ug/kg•min or norepinephrine <10ug/kg)

    6. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University Nanjing Jiangsu China 210009

    Sponsors and Collaborators

    • Southeast University, China

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Songqiao Liu, Principal Investigator, Southeast University, China
    ClinicalTrials.gov Identifier:
    NCT03237806
    Other Study ID Numbers:
    • 2012ZDIIKY22.0
    First Posted:
    Aug 3, 2017
    Last Update Posted:
    Mar 20, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Songqiao Liu, Principal Investigator, Southeast University, China
    ARDS,
    Transpulmonary pressure,
    Sedation

    Study Results

    No Results Posted as of Mar 20, 2018