Clinical trial

Safety And Efficacy Of 8 Hourly Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency ; A Prospective Pilot Study

Name
FF-2024-043
Description
Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural drainage hence it is important to be aware of safe techniques and procedures of insertion and also maintaining the pleural drainage systems to yield beneficial results. Most often, smaller catheters were deemed to be less effective in view of slower drainage rates and associated with high risk of blockage. However presently , in tertiary hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less painful and easily tolerated by patients. Hence, proper maintenance of SBICC should be undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations procedures. British Thoracic Society in their latest guidelines recommends the use of small bore intercostal chest drain as the first choice in draining pleural effusions. The success of draining pleural effusions with a SBICC has shown variable rates of success among different studies conducted. Most common issues faced are drain blockage and drain dislodgement. There is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining pleural effusions. This has lead us in conducting this research to compare the rates of partial or complete occlusions among normal saline flush with and without heparin saline lock in maintaining the patency of small bore intercostal chest catheter among patients with pleural diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains insertion.
Trial arms
Trial start
2024-03-15
Estimated PCD
2027-03-01
Trial end
2027-06-01
Status
Recruiting
Treatment
Heparin saline lock
Participants with intercostal chest catheter who underwent normal saline flushing with heparin saline lock
Arms:
Participants who underwent ICC with normal saline flushing and heparin lock
Without heparin saline lock
Participants with intercostal chest catheter who underwent normal saline flushing without heparin saline lock
Arms:
Participants who underwent ICC with normal saline flushing without heparin lock
Size
40
Primary endpoint
To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock
From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
Eligibility criteria
Inclusion Criteria: • All patients admitted in medical wards for pleural effusion who had small bore intercostal catheters inserted. Exclusion Criteria: * Patients with hydropneumothorax with small bore intercostal catheters * Patients with septated effusion planned for intrapleural fibrinolysis * Patients with severe coagulopathy * INR ≥ 1.5 * PT \> 37s * aPTT \> 100s * Patients with thrombocytopenia of less than 50 x 109/L * Patients who has not consented to be involved in the study * Patients with indwelling pleural catheters * Unconscious patients will be excluded from this study * Patients with poor GCS score will be excluded from this study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-03-26

1 organization

1 product

1 indication

Product
Heparin