RecruitingACTRN12623001109695

The Pneumothorax And Symptom Evaluation (PASE) Study: Bendopnoea in patients with pneumothorax


Sponsor

Institute for Respiratory Health

Enrollment

50 participants

Start Date

Apr 16, 2024

Study Type

Interventional

Conditions

Summary

Pneumothorax (collapsed lung) occurs when air leaks from the lung and accumulates between the chest wall and lung. The mechanism of breathlessness in pneumothorax is unclear, and symptoms vary between patients. Sometimes tubes need to be inserted between the ribs to drain the collected air and help the lung reinflate, and occasionally surgery is required. Currently, the effect of accumulated air in the pleural space and its association with diaphragmatic function and symptoms of breathlessness is not understood. Bendopnoea (breathlessness when bending forward) is an evolving clinical symptom that has been demonstrated as clinically useful in some heart and lung conditions. Whether bendopnoea is present in patients with pneumothorax, and its potential clinical usefulness has not yet been investigated. The PASE study is a pilot study to explore the incidence and clinical relevance of bendopnoea in patients with pneumothorax and may provide better understanding of breathlessness in pneumothorax.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study, called the PASE Study, is looking at a specific symptom called "bendopnoea" — which means feeling breathless when you bend forward — in people who have had a collapsed lung (pneumothorax). A pneumothorax happens when air leaks from the lung into the space between the lung and chest wall, causing the lung to partially or fully collapse. This is a painful and scary experience that can sometimes require a tube between the ribs to drain the trapped air. Researchers still don't fully understand why some people with a collapsed lung feel much more breathless than others, or how the buildup of air affects the diaphragm (the main breathing muscle). Bendopnoea is a symptom that has been found to be clinically useful in some heart and lung conditions, but it has never been studied in people with a collapsed lung before. This pilot study is open to adults (18 and over) who are being assessed for a spontaneous or inadvertently caused collapsed lung. You may not be eligible if you are pregnant, have significant fluid around the lung, are medically unstable, or have physical limitations that prevent bending forward. The study aims to better understand breathlessness in this condition and may help improve how patients are assessed and managed in the future.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will undergo the below assessments once at baseline, and in those patients who receive air drainage/lung re-inflation as per standard care and treating physician, they will repeat the bel

Participants will undergo the below assessments once at baseline, and in those patients who receive air drainage/lung re-inflation as per standard care and treating physician, they will repeat the below assessments one more time post lung re-inflation. Air drainage and lung re-inflation is at the discretion of the treating physician and is not a trial related intervention. The delegated study team will undertake and administer all the below assessments. All assessments will take approximately 20-25 minutes in total. 1. Bendopnoea test. The patient is sitting in a chair and is instructed to bend forward at the waist and aim to touch his/her ankles and maintain this position for up to 60 seconds. Patient will inform the investigator as soon as breathlessness bending forward (i.e., bendopnoea) occurs, The test will end as soon as symptom onset. Patients will be instructed to inform the staff member if they feel dizzy or lightheaded, and if so the test will be ceased. 2. Bendopnoea questionnaire. In a qualitative manner with the following question: “Since the onset of your symptoms, how has shortness of breath when bending forward impacted your day-to-day activities?” i. No limitation: I was not troubled by breathlessness when bending forward ii. Mild: I felt breathless when bending forward and performing an 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 wished 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 air drainage procedure, the question will be phrased: “since the procedure, how does shortness of breath when bending forward impact your day-to-day activities?” 3. Breathlessness questionnaire (Visual Analogue Scale). Breathlessness will be measured using a 100mm visual analogue scale (VAS) anchored by “no shortness of breath at all” and “maximum shortness of breath”. The mean of the VAS scores measured by two independent researchers will be documented. 4. Pain questionnaire (Visual Analogue Scale). Pain will be measured using a 100mm visual analogue scale (VAS) anchored by “no pain” and “worst pain”. The mean of the VAS scores measured by two independent researchers will be documented. 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 pneumothorax will be recorded. Pneumothorax Characteristics The size of the pneumothorax will be measured on standard erect PA inspiration chest radiographs (CXR) with the Light Index and Collins Method. The Light Index measures the average diameter of the lung and the hemithorax, cubing these diameters, and finding the rations whereas the Collins Method calculates the ‘sum of interpleural distances’ which estimates the pneumothorax size.


Locations(1)

WA, Australia

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