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

Severe Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03891212
• Other study ID #: 81770081
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2019
• Source: Xiangya Hospital of Central South University
• Contact: Lin, master
• Phone: +86 15211013273
• Email: linfengyu2212[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Severe pneumonia (SP) is a major complication of respiratory system diseases that is associated with high mortality and morbidity. If not treated correctly, it may rapidly lead to sepsis and multiple organ dysfunction syndrome. Randomized, controlled trials have confirmed that oxygenation is significantly better when patients are in the prone position than when they are in the supine position.But whether prone drainage is beneficial for rapid infection control on SP treatment has not been researched.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.

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.

The patients enrolled in this study should meet the diagnostic and inclusion criteria and provide written informed consent.

Diagnostic criteria The diagnostic criteria we will use for SP are based on the Infectious Diseases Society of America/American Thoracic Society guidelines.

The inclusion criteria are as follows:

1.Age ≥18 years and ≤75 years, male or female；2.Weight ≥40 kg and ≤100 kg；3.Meet the diagnostic criteria for SP；4.Need invasive mechanical ventilation；5.Provide signed informed consent

Non-inclusion criteria:

1. 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.

2. Respiratory reason

1. Inhaled nitric oxide (NOi) or almitrine bismesylate use before inclusion;b. Use of extracorporeal membrane oxygenation (ECMO) before inclusion.

3. 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.

4. 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.

Suspension criteria

The criteria for suspension of participation are as follows:

1.Poor compliance of investigators or patients;2.Occurrence of serious adverse events (AEs), complications, or fatal physiological changes;3.Voluntary withdrawal;4.Incomplete data; 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 statistical analysis will be performed using SAS software version 9.4 (SAS Institute, Cary, NC, USA). If the lower limit of the 95 % confidence interval is larger than a clinically meaningful difference, therapeutic effects of the experimental group are deemed to be clinically and statistically better than those of the control group. Two-sided tests will be performed for all the other statistical analyses. Cochran-Mantel-Haenszel χ2 tests or Fisher's exact tests will be used for comparison of categorical outcomes. Continuous outcomes will be analyzed by using Student's t test. p values ˂0.05 are considered to indicate statistical significance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Severe Pneumonia

Intervention

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.

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in C-reactive protein	Use C-reactive protein to assess the patient's lung infection status	On the tenth day after hospitalization
Primary	The changes in procalcitonin	Use procalcitonin to assess the patient's lung infection status	On the tenth day after hospitalization
Primary	The changes in d-dimer	Use d-dimer to assess the patient's lung infection status	On the tenth day after hospitalization
Primary	Chest x-ray changes	Use Chest x-ray to assess the patient's lung infection status	On the tenth day after hospitalization
Primary	Mortality rate after 28 days	Calculate patient 28-day mortality	28 days after admission
Primary	The time of total duration of ICU stay	Calculate The time of total duration of ICU stay	28 day
Primary	The time of mechanical ventilation	Calculate The time of mechanical ventilation	28 day
Primary	mortality	Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days	28 day
Primary	The time of antibiotic use	Calculate the time of antibiotic use	28 day
Primary	The time of bacterial cultures becoming negative	Calculate the time of bacterial cultures becoming negative	28 day
Primary	Daily sputum drainage	Calculate daily sputum drainage	On the tenth day after hospitalization