An interventional study of Pigtail catheter and Intercostal tube in Pleural Effusion, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Primary Aims:
To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding:
Secondary Aims:
To evaluate both techniques in terms of:
The pleural cavity is a space between the visceral and parietal pleura that contains a subtle amount of serous fluid (10 to 20ml) this fluid act as a lubricant to the pleural surface for proper gliding during respiration . Accumulation of abnormal amount of pleural fluid occurs under various pathological disorders, each of which manifests with a different physical and biochemical characteristics of the effused pleural fluid, it may be serous,pus,blood,or chyle.
Long standing undrained accumulated pleural fluid can lead to serious complications: like lung collapse leading to respiratory failure, fibrosis or scarring of the pleural membranes and underlying lung tissue, empyema, septic shock and even death in severe circumstance .
So we always seek to drain accumulated pleural fluid; Chest tubes connected to underwater seal have largely replaced open thoracotomy and rib resection in draining exudative pleural effusion and are now considered the standard method . However Intercostal tube drainage poses risks and hazards: large size of the tube that make it more painful more tissue destructive with more injury to intercostal arteries and nerves, the incisional insertion is also painful and results in more tissue dissection, moreover the tube is heavy as it need water seal to work so causing patient discomfort and increase liability of slippage.
Recently pigtail catheter has been employed to drain accumulated pleural fluid .pigtail catheter has many advantages: it has small caliber , which makes it less painful, less tissue destruction, less Injurious to intercostal nerves and vessels, Additionally it has a suction power with unidirectional valve which abolishes the need for underwater seal; thus avoiding the heavy weight of bottles and decreasing the risk of accidental slippage, inserted with trocar under ultrasonographic guidance decreasing liability of lung injury.
Previous studies compared pigtail versus chest tube in drainage of pleural effusion show .A total of 92 patients were included in the study, 57 (61.9%) patients in pigtail group and 35 (31.8%) in ICD group. Causes of pleural effusion included were pneumonia, malignancy,TB. the study had revealed that pigtail catheter had higher success rate less painful with no significant difference at mean duration of drainage..At other study data collected retrospectively from 60 patient aged more than 18 year 30 patients had an intercostal chest tube and 30 patients had pigtail catheters found that no statistically significant difference between pigtail and ICT at success rate and duration of drainage but pigtail found less painful with less incidence of complication regarding pneumothorax and catheter kinking and slippage .
However these studies have some limations first study was observational study not randomised, second study was retrospective with small sample size. Both studies have no clear definitions of outcomes , not focus on complications mainly wound pain as primary outcome and didn't answer the question of recurrence or drainage failure of pleural effusion after pigtail catheter drainage.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 142 interventional studies indexed under Pleural Effusion.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
composed of 40 patients in which pleural effusion will be drained using pigtail catheter under US guidance
Device: Pigtail catheter
composed of 40 patients in which pleural effusion will be drained using ICT
Device: Intercostal tube
Pigtail catheter will be inserted using Seldinger technique under US guidance to drainage exudative pleural effusion by a trained radiologist
Chest 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
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: 15 day
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".
Time frame: 0ne week
6) Duration of Hospital stay.
number of patients need hospitalization and duration they will spend at hospital
Time frame: "through study completion, an average of 1 year
7) Number of Patients Managed on Outpatient Settings.
Time frame: "through study completion, an average of 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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