Pleural Effusion
Conditions
Keywords
Pleural Effusion, Thoracentesis, Active Aspiration, Passive Aspiration, Procedural Complications, Gravity Drainage, Manual Aspiration
Brief summary
This single-blind randomized controlled trial (RCT) aims to compare the efficacy and safety of active manual aspiration versus passive gravity drainage during therapeutic thoracentesis for large symptomatic pleural effusions. A total of 60 eligible patients will be randomized into two equal groups. The active aspiration group will undergo fluid removal using manual syringe suction, while the passive aspiration group will undergo drainage via gravity. The primary outcomes of the study are the total procedure time and the volume of pleural fluid aspirated. Secondary outcomes include patient-reported pain (measured on a Numeric Rating Scale), patient-reported dyspnea (measured by the mMRC scale), the incidence of procedure-related cough, and the reason for procedure termination. The goal of this study is to determine which technique offers a better balance of efficiency and patient comfort.
Interventions
PROCEDUREActive Manual Syringe Aspiration
For the Active Manual Syringe Aspiration, the operator manually withdraws pleural fluid using a syringe attached to a 3-way stopcock and transfusion set. The fluid is then expelled into a collection bag.
PROCEDUREPassive Gravity Drainage
In Passive Gravity Drainage, after confirming proper needle placement with initial aspiration, the syringe is detached, and pleural fluid is allowed to drain passively by gravity through the transfusion set into a collection bag.
Sponsors
Sheikh Zayed Federal Postgraduate Medical Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of either gender. * Aged above 18 years. * With symptomatic large pleural effusion (either exudative or transudative). * Requiring therapeutic pleurocentesis. * Modified Medical Research Council (mMRC) dyspnea scale grade 3-4.
Exclusion criteria
* Uncorrected bleeding diathesis. * Chest wall cellulitis at the intended site of puncture. * Uncooperative patients. * Loculated pleural effusion. * Traumatic hemothorax. * Empyema thoracis. * Hydropneumothorax. * Patients who refused to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Fluid Aspirated | Immediately upon procedure completion (at the time of needle removal) and fluid extraction. | The total volume of pleural fluid successfully removed during the procedure, measured in milliliters (ml). |
| Procedure Time for Therapeutic Thoracentesis | Immediately upon procedure completion (at the time of needle removal) and fluid extraction. | The total duration of the thoracentesis procedure, measured in minutes, from the initial needle insertion until the procedure was terminated. Termination occurred when no more fluid could be drained, the target volume was reached, or due to patient complications like cough or discomfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Pain | Immediately upon procedure completion (at the time of needle removal) and fluid extraction. | The level of pain experienced by the patient during or immediately after the procedure, measured using the Numeric Rating Scale (NRS-11), an 11-point scale from 0 (no pain) to 10 (worst pain imaginable). |
| Patient-Reported Dyspnea | Immediately upon procedure completion (at the time of needle removal) and fluid extraction. | Description: The level of shortness of breath (dyspnea) was measured using the modified Medical Research Council (mMRC) Dyspnea Scale. The mMRC scale is a 5-point grade-based scale (Range: 0 to 4) used to categorize the severity of a patient's disability due to breathlessness. A higher score indicates a worse outcome. Grade 0: No breathlessness except with strenuous exercise. Grade 1: Shortness of breath when hurrying on level ground or walking up a slight hill. Grade 2: Walks slower than people of the same age on level ground because of breathlessness, or has to stop for breath when walking at own pace on level ground. Grade 3: Stops for breath after walking about 100 meters or after a few minutes on level ground. Grade 4: Too breathless to leave the house, or breathless when dressing or undressing. |
| Incidence of Cough | Immediately upon procedure completion (at the time of needle removal) and fluid extraction. | The occurrence of cough during or at the end of the procedure, recorded as a binary outcome (yes/no). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reason for Procedure Termination | Immediately upon procedure completion (at the time of needle removal) and fluid extraction. | The specific reason for stopping the procedure, categorized as: (1) target fluid volume (1-1.5L) achieved, or (2) terminated early due to complications (e.g., cough, chest discomfort) or spontaneous drainage cessation. |
Countries
Pakistan
Outcome results
None listed