Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion

NCT06099054 | Not Yet Recruiting

• 1 other identifier: Pigtail versus ICT
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary Aims: To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding:

1. 1.Various complications(mainly wound pain) that result from either therapeutic approach.
2. 2.Success of complete drainage.
3. 3.Compare the duration needed for complete drainage.
4. 4.Degree of patient's mobility that either technique permits.
5. 5.Percentage of patients that can be managed on outpatient settings by either approach

Conditions

Pleural Effusion

Keywords

pigtail versus intercostal tube

Outcome Measures

Primary Outcomes (4)

• 1) Degree of Pain/discomfort elicited by the Intervention:

  The visual analogue Scale from 0 TO 10 will be used to score reported pain or discomfort

  10 day

• 2) Adverse outcomes complicating either line of intervention

  (e.g., new onset pneumothorax or haemothorax, subcutaneous emphysema, fluid leakage around the wound, organ puncture, re-expansion pulmonary oedema, pneumonia, blockade of the drain, kinking or malposition).

  through study completion, an average of 1 year

• 3) Success of Complete Drainage

  Number of patients with complete drainage: Complete drainage will be considered if all the following conditions are met: Amount of drained fluid \< 50 cc of serous/ hemo-serous fluid (no pus or gross bleeding) for two successive days. No accompanying air leak in the previous 12 hours. Radiological resolution (no residual free pleural fluid seen by chest US and lung expansion against chest wall as detected by chest US and CXR)

  through study completion, an average of 1 year

• 4) Duration needed for Complete Drainage:

  Duration (in days) will be counted from the day of drain insertion to the day of drain removal

  15 day

Secondary Outcomes (3)

• 5) Degree of Patient's Mobility:

  0ne week

• 6) Duration of Hospital stay.

  "through study completion, an average of 1 year

• 7) Number of Patients Managed on Outpatient Settings.

  "through study completion, an average of 1 year

Study Arms (2)

pigtail group

EXPERIMENTAL

composed of 40 patients in which pleural effusion will be drained using pigtail catheter under US guidance

Device: Pigtail catheter

ICT group

ACTIVE COMPARATOR

composed of 40 patients in which pleural effusion will be drained using ICT

Device: Intercostal tube

Interventions

Pigtail catheter DEVICE

Pigtail catheter will be inserted using Seldinger technique under US guidance to drainage exudative pleural effusion by a trained radiologist

pigtail group

Intercostal tube DEVICE

Chest tube will be inserted according to BTS guideline for insertion of ICT by a trained thoracic surgeon

ICT group

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years.
• Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage.
• Loculated pleural effusion where positive colour doppler sign is preserved

You may not qualify if:

• Traumatic or iatrogenic pleural effusion.
• Transudative pleural effusion (subjected to treatment of the underlying cause and diuretic therapy).
• Exudative pleural effusion amenable for medical treatment
• Large-volume, easily accessible, free non-loculated empyema.
• Pleural infections with loculated pleural effusion but showing negative colour doppler sign.
• Malignant pleural effusion with potentially inexpnasible underlying lung (thick pleural peel, central airway obstruction), life expectancy \< 1 month or asymptomatic.
• Patients with uncorrected bleeding tendency (INR \> 1.5, Platelet count \< 50.000/mm3).
• Inability or refusal to sign written consent.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (14)

• Chubb SP, Williams RA. Biochemical Analysis of Pleural Fluid and Ascites. Clin Biochem Rev. 2018 May;39(2):39-50.

  PMID: 30473591 BACKGROUND

• Karkhanis VS, Joshi JM. Pleural effusion: diagnosis, treatment, and management. Open Access Emerg Med. 2012 Jun 22;4:31-52. doi: 10.2147/OAEM.S29942. eCollection 2012.

  PMID: 27147861 BACKGROUND

• Broaddus VC, Light RW. Pleural effusion. In:Broaddus VC, Ernst JD, King TE, et al, eds. Murray and Nadel's Textbook of Respiratory Medicine. 7th ed. Philadelphia, PA: Elsevier; 2022:chapater108

  BACKGROUND

• Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.

  PMID: 19022041 BACKGROUND

• Munnell ER. Thoracic drainage. Ann Thorac Surg. 1997 May;63(5):1497-502. doi: 10.1016/s0003-4975(97)00082-9.

  PMID: 9146363 BACKGROUND

• Liu YH, Lin YC, Liang SJ, Tu CY, Chen CH, Chen HJ, Chen W, Shih CM, Hsu WH. Ultrasound-guided pigtail catheters for drainage of various pleural diseases. Am J Emerg Med. 2010 Oct;28(8):915-21. doi: 10.1016/j.ajem.2009.04.041. Epub 2010 Feb 25.

  PMID: 20825924 BACKGROUND

• Gammie JS, Banks MC, Fuhrman CR, Pham SM, Griffith BP, Keenan RJ, Luketich JD. The pigtail catheter for pleural drainage: a less invasive alternative to tube thoracostomy. JSLS. 1999 Jan-Mar;3(1):57-61.

  PMID: 10323171 BACKGROUND

• Khare R*, Anand K, Agrawal P, Yadav A. Comparative analysis of pigtail catheter versus intercostal tube drainage for pleural effusion: a tertiary centre study. Khare R et al. Int Surg J. 2023 Jan;10(1):105-109

  BACKGROUND

• Mathis G. Pleura. In: Mathis G, ed. Chest sonography. 3rd ed. Heidelberg: Springer-Verlag, 2011;30-32

  BACKGROUND

• Yang PC, Luh KT, Chang DB, Wu HD, Yu CJ, Kuo SH. Value of sonography in determining the nature of pleural effusion: analysis of 320 cases. AJR Am J Roentgenol. 1992 Jul;159(1):29-33. doi: 10.2214/ajr.159.1.1609716.

  PMID: 1609716 BACKGROUND

• Reuß J., "Sonographic imaging of the pleura: Nearly 30 years experience," European Journal of Ultrasound, vol. 3, no. 2, pp. 125-139, 1996.

  BACKGROUND

• SELDINGER SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol (Stockh). 1953 May;39(5):368-76. doi: 10.3109/00016925309136722. No abstract available.

  PMID: 13057644 BACKGROUND

• Laws D, Neville E, Duffy J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the insertion of a chest drain. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii53-9. doi: 10.1136/thorax.58.suppl_2.ii53. No abstract available.

  PMID: 12728150 BACKGROUND

• Fox V, Gould D, Davies N, Owen S. Patients' experiences of having an underwater seal chest drain: a replication study. J Clin Nurs. 1999 Nov;8(6):684-92. doi: 10.1046/j.1365-2702.1999.00307.x.

  PMID: 10827615 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Hossam El-din Galal, Prof.Dr

  Assiut Univeristy

  PRINCIPAL INVESTIGATOR

• Hamdy Mohammad Ibrahim, lecturer

  Assiut Univeristy

  STUDY DIRECTOR

• Sara Mohammed Hashem, lecturer

  Assiut Univeristy

  STUDY DIRECTOR

Central Study Contacts

Hossam Hassan, master

CONTACT

01008933979; hh6173303@gmail.com

Hamdy Ibrahim, lecturer

CONTACT

01067646141; hamdyradiologist@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Model Details: Patients will be randomised to either group: Group I (Intervention group): in which pleural effusion will be drained using pigtail catheter under US guidance. Group II (Control group): in which pleural effusion will be drained using ICT

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 25, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 25, 2028
• Last Updated: October 25, 2023

Record last verified: 2023-10