None listed
Conditions
Brief summary
Pleural effusions (excess fluid accumulation between the lung and chest wall) affect 60,000 Australians every year and can arise from a wide range of causes including cancer, heart and liver failure. Pleural effusions often cause disabling breathlessness. Drainage of the fluid (usually requires inserting tubes between the ribs) can relieve symptoms, but the benefits vary among patients. The mechanism by which pleural effusion causes breathlessness remains unclear. A reliable method of identifying the patients likely to respond to drainage may help reduce unnecessary, painful procedures and their associated complications and healthcare costs. The PLeural Effusion And Symptom Evaluation project aims address this knowledge gap. Bendopnoea (breathlessness on bending forward) is a common clinical complaint in patients with pleural effusion but has not been previously studied. Our pilot data found that bendopnoea was significantly associated with the presence of pleural effusion. The PLEASE-3 study will aim to evaluate the value of bendopnoea as a screening test for effusion-related breathlessness, its predictive value of symptomatic benefits from fluid drainage and explore the physiological mechanisms underlying bendopnoea. Participation on this study involves completing questionnaires, performing a bendopnoea test, breathing test via spirometry and a 6-Minute walk test. If there is fluid needed to be drained first, the tests will be performed once before and once after the fluid is drained (within 36 hours of removal of the fluid). The results of these 2 sets will be compared to each other to find out the difference, if any, of removing the fluid.
Interventions
The following parameters will be assessed using a range of validated tools for all patients 1. At baseline (pre-drainage) and, 2. For those proceeding to pleural fluid drainage, at 24-36 hours post drainage. For patients with intercostal catheter (ICC) or indwelling pleural catheter (IPC), this will be after the pleural fluid is completely drained. A) Bendopnoea is assessed: 1. in a qualitative manner (as modified from Baeza-Trinidad et al) with the following question: a. “In the last 7 days, how does shortness of breath when bending forward impact your day-to-day activities?” i. No limitation: I was not troubled breathlessness when bending forward ii. Mild: I felt breathless when bending forward and performing activity (e.g., tying shoelaces) but can still perform activities without limitation or rest. iii. Moderate: I had to stop and take breaks from bending forward to complete what I wish to do (e.g. I have to bend down several times to complete tying the laces of both shoes). iv. Severe: I was too breathless to bend forward b. After the pleural procedure the question will be phrased: “how does shortness of breath when bending forward impact your day-to-day activity now” 2. With objective testing, as per published studies: a. Patient sitting in a chair is instructed to bend forward at the waist and aim to touch his/her ankles and maintain this position for 60 seconds. Patient will inform the investigator as soon as breathlessness occurs, and the time of onset of bendopnoea recorded. b. Bendopnoea is assessed: i. As a continuous variable (time to breathlessness) and ii. As present or absent during the test. The semi-quantitative question and objective test in chair will be administered by a respiratory physician and it will only take 5 minutes to complete. Degree of breathlessness and impairment on functional activities: Breathlessness will be measured using a validated 100mm visual analog scale (VAS) anchored by “no shortness of breath at all” and “maximum shortness of breath”. VAS, has been successfully used in several of our RCTs on malignant effusion management (e.g. TIME-2, -3 and AMPLE-1) with the lower end of the 95%CI (14 mm) used as the minimum clinically important difference. The VAS scale will be provided by a respiratory physician and will only take 1 minute to complete. The impact of breathlessness on function This will be measured with a standard 6-minute walk test performed by trained operators as per guidelines. This is a well validated and commonly used measure. Patient characteristics Breathlessness can be a result of concurrent illnesses (e.g., heart failure, COPD etc) and intrathoracic (e.g., pulmonary emboli) or extrathoracic factors (e.g., muscle wasting) which will be captured from case notes. Height, weight and body mass index will be recorded. Cardio-pulmonary status (respiratory and heart rates, blood pressure and oxygen saturation) and the aetiology of the effusion will be recorded. Spirometric volumes (FEV1 and FVC) will be performed according to the American Thoracic Society criteria. This will be assessed by a respiratory physician and will take approximately 5 minutes to complete. Echocardiogram will not be requested specifically for this study; however if the patient has echocardiogram studies performed for their clinical need, the data will be recorded. Pleural effusion characteristics The size of the effusion will be graded semi-quantitatively on chest radiographs (CXR) using the scores (0 to 5) as published by Light et al, and as our lead investigators have used in prior publications. The volume of fluid drained and its biochemistry (protein, LDH, pH, etc) will be recorded. Evaluation of diaphragmatic dysfunction Pleural ultrasound (B-mode and M-mode) will be performed at the bedside by a respiratory physician to assess both hemi-diaphragms using a real-time scanner with 3.5 and 12-MHz sector transducer (as per published methods) in the upright position: to assess diaphragm shape (normal domed, flattened or inverted) and movement (normal, reduced or paradoxical). This will take approximately 5 minutes to complete.
Sponsors
Eligibility
Inclusion criteria
In- and out-patients with symptomatic breathlessness referred to the SCGH Pleural Service and the Respiratory Department of Westmead Hospital for assessment and/or pleural fluid drainage.
Exclusion criteria
• Age <18 years • Mechanical limitations in bending forward (e.g., spinal conditions or large abdominal mass) • Pregnancy/lactation. • Inability to consent and/or comply with protocol