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

Primary Purpose

Pleural Effusion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pigtail catheter
Intercostal tube
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring pigtail versus intercostal tube

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 18 years. Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage. Loculated pleural effusion where positive colour doppler sign is preserved Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    pigtail group

    ICT group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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: How confident they are moving with the chest drain without limitation in activities. How confident they are moving with the chest drain without concerns about accidental slippage/removal of the drainage set. 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.

    Full Information

    First Posted
    September 22, 2023
    Last Updated
    October 23, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099054
    Brief Title
    Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion
    Official Title
    Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2027 (Anticipated)
    Study Completion Date
    May 25, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Primary Aims: To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding: Various complications(mainly wound pain) that result from either therapeutic approach. Success of complete drainage. Compare the duration needed for complete drainage. Secondary Aims: To evaluate both techniques in terms of: Degree of patient's mobility that either technique permits. Percentage of patients that can be managed on outpatient settings by either approach
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pleural Effusion
    Keywords
    pigtail versus intercostal tube

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pigtail group
    Arm Type
    Experimental
    Arm Description
    composed of 40 patients in which pleural effusion will be drained using pigtail catheter under US guidance
    Arm Title
    ICT group
    Arm Type
    Active Comparator
    Arm Description
    composed of 40 patients in which pleural effusion will be drained using ICT
    Intervention Type
    Device
    Intervention Name(s)
    Pigtail catheter
    Intervention Description
    Pigtail catheter will be inserted using Seldinger technique under US guidance to drainage exudative pleural effusion by a trained radiologist
    Intervention Type
    Device
    Intervention Name(s)
    Intercostal tube
    Intervention Description
    Chest tube will be inserted according to BTS guideline for insertion of ICT by a trained thoracic surgeon
    Primary Outcome Measure Information:
    Title
    1) Degree of Pain/discomfort elicited by the Intervention:
    Description
    The visual analogue Scale from 0 TO 10 will be used to score reported pain or discomfort
    Time Frame
    10 day
    Title
    2) Adverse outcomes complicating either line of intervention
    Description
    (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
    Title
    3) Success of Complete Drainage
    Description
    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
    Title
    4) Duration needed for Complete Drainage:
    Description
    Duration (in days) will be counted from the day of drain insertion to the day of drain removal
    Time Frame
    15 day
    Secondary Outcome Measure Information:
    Title
    5) Degree of Patient's Mobility:
    Description
    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: How confident they are moving with the chest drain without limitation in activities. How confident they are moving with the chest drain without concerns about accidental slippage/removal of the drainage set. 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
    Title
    6) Duration of Hospital stay.
    Description
    number of patients need hospitalization and duration they will spend at hospital
    Time Frame
    "through study completion, an average of 1 year
    Title
    7) Number of Patients Managed on Outpatient Settings.
    Time Frame
    "through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years. Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage. Loculated pleural effusion where positive colour doppler sign is preserved Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hossam Hassan, master
    Phone
    01008933979
    Email
    hh6173303@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hamdy Ibrahim, lecturer
    Phone
    01067646141
    Email
    hamdyradiologist@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hossam El-din Galal, Prof.Dr
    Organizational Affiliation
    Assiut Univeristy
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Hamdy Mohammad Ibrahim, lecturer
    Organizational Affiliation
    Assiut Univeristy
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sara Mohammed Hashem, lecturer
    Organizational Affiliation
    Assiut Univeristy
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
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    30473591
    Citation
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    Citation
    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.
    Results Reference
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    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
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    Citation
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    Results Reference
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    PubMed Identifier
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    Citation
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    Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion

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