Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency

NCT06314620 | Recruiting

• 1 other identifier: FF-2024-043
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock

  Participants who underwent intercostal chest catheter insertion who received 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

Secondary Outcomes (5)

• To determine the onset of intercostal chest catheter occlusions (in hours)

  From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain

• To determine the change of hemoglobin (in g/dL) post ICC insertion

  From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain

• To determine the change of platelet (in 10 9/L) post ICC insertion

  From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain

• To determine the adverse effects of heparin saline lock

  From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain

• To assess the number of fenestrations occluded (in numbers from 0-5) with fibrin or blood clots

  From the time of randomization to the time of the end of study up to up to 30 days post insertion of chest drain

Study Arms (2)

Participants who underwent ICC with normal saline flushing and heparin lock

ACTIVE COMPARATOR

Participants who underwent intercostal chest catheter with normal saline flushing with heparin lock. Instillation done with 20 mls of Normal Saline flush followed by heparin saline lock, every 6 hours by a three way stopcock.

Drug: Heparin saline lock

Participants who underwent ICC with normal saline flushing without heparin lock

ACTIVE COMPARATOR

Participants who underwent intercostal chest catheter with normal saline flushing without heparin lock. Instillation done with 20 mls of Normal Saline flush , every 6 hours by a three way stopcock.

Other: Without heparin saline lock

Interventions

Heparin saline lock DRUG

Participants with intercostal chest catheter who underwent normal saline flushing with heparin saline lock

Participants who underwent ICC with normal saline flushing and heparin lock

Without heparin saline lock OTHER

Participants with intercostal chest catheter who underwent normal saline flushing without heparin saline lock

Participants who underwent ICC with normal saline flushing without heparin lock

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted in medical wards for pleural effusion who had small bore intercostal catheters inserted.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

National University of Malaysia

Kuala Lumpur, Kuala Lumpur, 53300, Malaysia

RECRUITING

Related Publications (11)

• Horsley A, Jones L, White J, Henry M. Efficacy and complications of small-bore, wire-guided chest drains. Chest. 2006 Dec;130(6):1857-63. doi: 10.1378/chest.130.6.1857.

  PMID: 17167009 RESULT

• Maskell N; British Thoracic Society Pleural Disease Guideline Group. British Thoracic Society Pleural Disease Guidelines--2010 update. Thorax. 2010 Aug;65(8):667-9. doi: 10.1136/thx.2010.140236. No abstract available.

  PMID: 20685739 RESULT

• Keeling AN, Leong S, Logan PM, Lee MJ. Empyema and effusion: outcome of image-guided small-bore catheter drainage. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):135-41. doi: 10.1007/s00270-007-9197-0. Epub 2007 Oct 18.

  PMID: 17943347 RESULT

• Davies HE, Merchant S, McGown A. A study of the complications of small bore 'Seldinger' intercostal chest drains. Respirology. 2008 Jun;13(4):603-7. doi: 10.1111/j.1440-1843.2008.01296.x. Epub 2008 Apr 14.

  PMID: 18422864 RESULT

• Porcel JM, Azzopardi M, Koegelenberg CF, Maldonado F, Rahman NM, Lee YC. The diagnosis of pleural effusions. Expert Rev Respir Med. 2015;9(6):801-15. doi: 10.1586/17476348.2015.1098535. Epub 2015 Oct 8.

  PMID: 26449328 RESULT

• Parulekar W, Di Primio G, Matzinger F, Dennie C, Bociek G. Use of small-bore vs large-bore chest tubes for treatment of malignant pleural effusions. Chest. 2001 Jul;120(1):19-25. doi: 10.1378/chest.120.1.19.

  PMID: 11451810 RESULT

• Mehra S, Heraganahally S, Sajkov D, Morton S, Bowden J. The effectiveness of small-bore intercostal catheters versus large-bore chest tubes in the management of pleural disease with the systematic review of literature. Lung India. 2020 May-Jun;37(3):198-203. doi: 10.4103/lungindia.lungindia_229_19.

  PMID: 32367840 RESULT

• Collop NA, Kim S, Sahn SA. Analysis of tube thoracostomy performed by pulmonologists at a teaching hospital. Chest. 1997 Sep;112(3):709-13. doi: 10.1378/chest.112.3.709.

  PMID: 9315804 RESULT

• Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28.

  PMID: 26022948 RESULT

• Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.

  PMID: 26075094 RESULT

• Shaikh N. Heparin-induced thrombocytopenia. J Emerg Trauma Shock. 2011 Jan;4(1):97-102. doi: 10.4103/0974-2700.76843.

  PMID: 21633576 RESULT

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Mohamed Faisal Abdul Hamid, MBBS (IIUM)

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Faisal Abdul Hamid, MBBS (IIUM)

CONTACT

0391455555; faisal.hamid@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 18, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)