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The Effect of Prone Position Drainage on the Efficacy of Severe Pneumonia,a Multicenter Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891212
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
Enrollment criteria and clinical data collection: follow the principles of medical ethics, the development of inclusion and exclusion criteria, Select all eligible patients with severe pneumonia(SP) who were admitted to the hospital during the study date.The diagnostic criteria we will use for SP are based on the Infectious Diseases Society of America/American Thoracic Society guidelines.Primary outcome measures:a.CURB-65 Score for Pneumonia Severity;b.The changes in inflammation and coagulation indicators: C-reactive protein, procalcitonin, and d-dimer;c.Chest x-ray changes;d.Mortality rate after 28 days;e.The time of mechanical ventilation, total duration of ICU stay, hospitalization, and antibiotic use;f.The time of bacterial cultures becoming negative;g.Daily sputum drainage.The aim of this study is to evaluate the anti-infective effectiveness and safety of prone position drainage compared with supine position on SP treatment.

Condition or disease Intervention/treatment Phase
Severe Pneumonia Behavioral: Placed in prone position for at least 16 consecutive hours a day. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Using a central randomization system, participants will be randomized (1:1) into groups receiving either placed in prone position or in supine position (within 24 h of diagnosis of SP) for 5-7 days with a 28-day follow-up. Patients assigned to the prone group had to be turned within the first hour following randomization. They were placed in prone position for at least 16 consecutive hours.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Prone Position Drainage on the Efficacy of Severe Pneumonia,a Multicenter Randomized Controlled Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: The prone group
Patients assigned to the prone group had to be turned within the first hour following randomization. They were placed in prone position for at least 16 consecutive hours.
Behavioral: Placed in prone position for at least 16 consecutive hours a day.
Patients assigned to the prone group had to be turned within the first hour following randomization. They were placed in prone position for at least 16 consecutive hours. Patients assigned to the control group had to be turned within the first hour following randomization. They were placed in supine position for at least 16 consecutive hours.

No Intervention: The supine group
Patients assigned to the supine group had to be turned within the first hour following randomization. They were placed in supine position for at least 16 consecutive hours.



Primary Outcome Measures :
  1. The changes in C-reactive protein [ Time Frame: On the tenth day after hospitalization ]
    Use C-reactive protein to assess the patient's lung infection status

  2. The changes in procalcitonin [ Time Frame: On the tenth day after hospitalization ]
    Use procalcitonin to assess the patient's lung infection status

  3. The changes in d-dimer [ Time Frame: On the tenth day after hospitalization ]
    Use d-dimer to assess the patient's lung infection status

  4. Chest x-ray changes [ Time Frame: On the tenth day after hospitalization ]
    Use Chest x-ray to assess the patient's lung infection status

  5. Mortality rate after 28 days [ Time Frame: 28 days after admission ]
    Calculate patient 28-day mortality

  6. The time of total duration of ICU stay [ Time Frame: 28 day ]
    Calculate The time of total duration of ICU stay

  7. The time of mechanical ventilation [ Time Frame: 28 day ]
    Calculate The time of mechanical ventilation

  8. mortality [ Time Frame: 28 day ]
    Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days

  9. The time of antibiotic use [ Time Frame: 28 day ]
    Calculate the time of antibiotic use

  10. The time of bacterial cultures becoming negative [ Time Frame: 28 day ]
    Calculate the time of bacterial cultures becoming negative

  11. Daily sputum drainage [ Time Frame: On the tenth day after hospitalization ]
    Calculate daily sputum drainage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years and ≤75 years, male or female
  • Weight ≥40 kg and ≤100 kg
  • Meet the diagnostic criteria for SP
  • Need invasive mechanical ventilation
  • Provide signed informed consent

Exclusion Criteria:

  • Contraindication for prone positioning:a. Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mmHg;b. Massive hemoptysis requiring an immediate surgical or interventional radiology procedure; c. Tracheal surgery or sternotomy during the previous 15 days;d. Serious facial trauma or facial surgery during the previous 15 days;e. Deep venous thrombosis treated for less than 2 days; f. Cardiac pacemaker inserted in the last 2 days;g. Unstable spine, femur, or pelvic fractures;h. Mean arterial pressure lower than 65 mm Hg;i. Pregnant women; j. Single anterior chest tube with air leaks.
  • Respiratory reason:a. Inhaled nitric oxide (NOi) or almitrine bismesylate use before inclusion;b. Use of extracorporeal membrane oxygenation (ECMO) before inclusion.
  • Clinical context:a. Lung transplantation;b. Burns on more than 20 % of the body surface;c. Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation(NIV);d. Underlying disease with a life expectancy of less than one year;e. NIV delivered for more than 24 hours before inclusion.
  • Other non-inclusion criteria :a. End-of-life decision before inclusion;b. Inclusion in another research protocol in the previous 30 days with mortality as the main end-point;c. Prone positioning before inclusion;d. Subject deprived of freedom, minor, subject under a legal protective measure;e. Opposition from next of kin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891212


Contacts
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Contact: Lin, master +86 15211013273 linfengyu2212@126.com
Contact: Pinhua Pan, Doctor (+86)13574810968 pinhuapan668@126.com

Locations
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China, Hunan
Xiangya Hospital
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Xiangya Hospital of Central South University
National Natural Science Foundation of China
Investigators
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Study Director: Pinhua Pan, Doctor Xiangya Hospital of Central South University
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03891212    
Other Study ID Numbers: 81770081
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangya Hospital of Central South University:
Prone Position
Treatment Outcome
Respiration, Artificial
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections