Primary Aims:
To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding:
1. Various complications(mainly wound pain) that result from either therapeutic approach. 2. Success of complete drainage. 3. Compare the duration needed for complete drainage.
Secondary Aims:
To evaluate both techniques in terms of:
1. Degree of patient's mobility that either technique permits. 2. Percentage of patients that can be managed on outpatient settings by either approach
Age > 18 years.
Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage.
Loculated pleural effusion where positive colour doppler sign is preserved
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.
Parallel
Pigtail catheter
DevicePigtail catheter will be inserted using Seldinger technique under US guidance to drainage exudative pleural effusion by a trained radiologist
Intercostal tube
DeviceChest tube will be inserted according to BTS guideline for insertion of ICT by a trained thoracic surgeon
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
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).
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)
4) Duration needed for Complete Drainage:
Duration (in days) will be counted from the day of drain insertion to the day of drain removal
5) Degree of Patient's Mobility:
A modification of a 6-item survey assessing the patient's sense of security with a chest drain will be used. Patients are to be asked to report: 1. How confident they are moving with the chest drain without limitation in activities. 2. How confident they are moving with the chest drain without concerns about accidental slippage/removal of the drainage set. 3. How confident they are moving with the chest drain without concerns about accidental damage/breakage to the drainage set. Patients are to report their answer to this question on a 5-point Likert's scale, where 5 meant "definitely yes" and 1 meant "definitely not".
6) Duration of Hospital stay.
number of patients need hospitalization and duration they will spend at hospital
7) Number of Patients Managed on Outpatient Settings.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
