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

NCT03891212 | Unknown DMC

• 1 other identifier: 81770081
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Pneumonia

Keywords

Prone Position; Treatment Outcome; Respiration, Artificial

Outcome Measures

Primary Outcomes (11)

• The changes in C-reactive protein

  Use C-reactive protein to assess the patient's lung infection status

  On the tenth day after hospitalization

• The changes in procalcitonin

  Use procalcitonin to assess the patient's lung infection status

  On the tenth day after hospitalization

• The changes in d-dimer

  Use d-dimer to assess the patient's lung infection status

  On the tenth day after hospitalization

• Chest x-ray changes

  Use Chest x-ray to assess the patient's lung infection status

  On the tenth day after hospitalization

• Mortality rate after 28 days

  Calculate patient 28-day mortality

  28 days after admission

• The time of total duration of ICU stay

  Calculate The time of total duration of ICU stay

  28 day

• The time of mechanical ventilation

  Calculate The time of mechanical ventilation

  28 day

• mortality

  Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days

  28 day

• The time of antibiotic use

  Calculate the time of antibiotic use

  28 day

• The time of bacterial cultures becoming negative

  Calculate the time of bacterial cultures becoming negative

  28 day

• Daily sputum drainage

  Calculate daily sputum drainage

  On the tenth day after hospitalization

Study Arms (2)

The prone group

EXPERIMENTAL

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.

The supine group

NO INTERVENTION

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.

Interventions

Placed in prone position for at least 16 consecutive hours a day. BEHAVIORAL

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.

The prone group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Pneumonia; Respiratory Aspiration

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pinhua Pan, Doctor

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Lin, master

CONTACT

+86 15211013273; linfengyu2212@126.com

Pinhua Pan, Doctor

CONTACT

(+86)13574810968; pinhuapan668@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 26, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

CN (1)