Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03891212
Other study ID # 81770081
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06114784 - Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study
Completed NCT03870243 - Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia N/A
Completed NCT05158842 - Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study N/A
Suspended NCT04310865 - Yinhu Qingwen Granula for the Treatment of Severe CoVID-19 Phase 2/Phase 3
Completed NCT04457505 - One Year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19
Terminated NCT04794803 - Reparixin in COVID-19 Pneumonia - Efficacy and Safety Phase 2/Phase 3
Recruiting NCT01068990 - Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients
Completed NCT03831906 - Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia) N/A
Recruiting NCT05768204 - Research on the Treatment of Severe Community-acquired Pneumonia in Children Phase 4
Recruiting NCT04359667 - Serum IL-6 and Soluble IL-6 Receptor in Severe COVID-19 Pneumonia Treated With Tocilizumab
Not yet recruiting NCT04395066 - Molecular Diagnosis and Prognosis of Severe Pulmonary Infection Immunosuppressed Hosts
Not yet recruiting NCT05143593 - Species-specific Bacterial Detector for Fast Pathogen Diagnosis of Severe Pneumonia N/A
Completed NCT05663905 - Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients Phase 4
Not yet recruiting NCT04282928 - Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells for the Treatment of Severe Viral Pneumonian Phase 1
Completed NCT01192789 - Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age N/A
Completed NCT00455468 - Randomized Controlled Trial (RCT) in Children With Severe Pneumonia N/A
Completed NCT03588377 - Impact of Pulse Oximetry on Hospital Referral Acceptance in Children Under 5 With Severe Pneumonia N/A
Recruiting NCT04955756 - Early Identification and Severity Prediction of Acute Respiratory Infectious Disease N/A
Recruiting NCT04882436 - Construction of Special Disease Cohort Database and Biological Sample Holographic Database of Severe Pneumonia