Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427538
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-10
Brief Title:
Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELIEF
Brief Summary:
Infections of the pleural space are common and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid Chest drains can get blocked by the drainage fluid and material For this reason it is thought that flushing the chest drain with saline solution can help maintain the patency of the tube This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space
Detailed Description:
There are no randomized controlled trials RCTs evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes Most studies of 16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency however this practice has never been studied prospectively or in RCTs Regular flushing eg 20-30 ml saline every 6 h via a three-way tap is recommended for small chest drains by the British Thoracic Society BTS 2010 Guidelines This practice is followed variably by some and not used by others Importantly the role of this practice in successful drainage of infected fluid and patient-centric outcomes has not been investigated Inconsistent flushing practices confound the interpretation of therapeutic modalities such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None