RecruitingACTRN12625000235404

A pilot study to assess a lung function tests as a monitoring tool in patients with pneumothorax.

The PneumoFOT study: a pilot feasibility study to explore assessment of respiratory mechanics using Forced Oscillation Technique (FOT) in patients with all causes of pneumothorax.

Sponsor

Institute of respiratory health

Enrollment

40 participants

Start Date

Apr 12, 2025

Study Type

Interventional

Conditions

Traumatic pnuemothorax Primary spontaneous pneumothorax Pneumothorax Secondary spontaneous pneumothorax Iatrogenic pneumothorax

Summary

Pneumothorax, commonly called a collapsed lung, occurs when air leaks out of the lung and accumulates between the lung and the chest wall. This condition can affect individuals with healthy lungs and those with underlying conditions such as emphysema. It can also result from trauma or complications from procedures like lung biopsies. Patients with pneumothorax may remain asymptomatic or have trouble breathing due to the collapsed lung, reduced lung capacity from underlying diseases, or interference with diaphragm function caused by the accumulated air. The exact cause of these symptoms can sometimes be unclear. Treatment may involve inserting a chest tube between the ribs to remove the air and reinflate the lung, which helps alleviate symptoms. Currently, no formal lung function assessments are specifically for patients with pneumothorax. Traditional lung function tests, such as spirometry, require forceful breathing manoeuvres and are contraindicated in patients with pneumothorax as they can exacerbate the air-leak and increase symptoms. The Forced Oscillation Technique (FOT) assesses the mechanical function of the airways and lungs without requiring patient effort. Patients can breathe at rest, while FOT measures the mechanical properties of the lungs. FOT is safe in infants, pregnant women and in sick patients admitted to the intensive care unit. This pilot study aimed to explore the feasibility of performing FOT in patients with pneumothorax and provide insights into the respiratory mechanics of the lungs in pneumothorax. We will correlate FOT parameters with patient symptoms and radiological findings and evaluate if FOT can be a surrogate method to monitor pneumothorax recovery.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

A pneumothorax — commonly called a collapsed lung — occurs when air leaks out of the lung into the space between the lung and chest wall. This can happen spontaneously in otherwise healthy people or as a result of trauma, lung disease, or medical procedures. Symptoms can range from mild discomfort to severe breathlessness. Currently, doctors can't easily measure lung function during pneumothorax because the standard test (spirometry) requires forceful breathing that could make the condition worse. This study is testing a gentle, effort-free breathing test called the Forced Oscillation Technique (FOT), which works by sending small pressure pulses through normal breathing. Researchers want to see whether FOT measurements can track the recovery of lung function as pneumothorax resolves. You may be eligible if you are an adult (18 or older) with a new diagnosis of pneumothorax — whether you are in hospital or attending as an outpatient. People on ventilators, with severe breathlessness, or who are pregnant are not eligible. This is a non-invasive, low-risk study that does not involve any treatment changes.

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

PneumoFOT study is a feasibility study to assess if Forced Oscillation Technique (FOT) can be done in patients with all causes of pneumothorax. This study will enrol 40 consecutive patients with pneumothorax who presents to Sir Charles Gairdner Hospital (SCGH), Perth, Western Australia. The patients may be in-patient, out-patients or individuals who visit emergency services at SCGH. The inclusion criteria are all adult (>/= 18 years) in and out-patients referred for assessment of a new diagnosis of all causes of pneumothorax. The FOT machine is owned by the Department of Respiratory medicine, Airways unit and does not need additional charges. The FOT machine is manufactured by Thorasys medical system inc based in Montreal, Canada. FOT machine is a simple handheld portable device that delivers different frequency sound waves through the mouthpiece to the respiratory system. The frequency of assessment includes starting from 5 hertz to 35 hertz. The final assessment includes the parameters of impedance of the lung, which includes the resistance(R) of airways at 5hz and high frequency (20 hertz) and reactance (x) at both high and low frequencies. We will also measure the resonant frequency (Fres) and the area of reactance (the area under X5 till the resonant frequency). The FOT is usually conducted by the researcher Dr Niranjan Ananda Setty, in his absence the staff will be trained to conduct FOT. A training log will be maintained. The adherence will be monitored by direct observation and the recordings of the FOT, which will be saved in the safe folder. The assessment will include the following parameters: 1. At baseline (day 0) - baseline characteristics including medical history, Visual Analogue Scale for breathlessness and pain, chest x-ray findings, and FOT readings. Patient baseline characteristics recorded included age, sex, height, weight, smoking status, pack-years, co-morbid illnesses like asthma, COPD, bronchiectasis, interstitial lung disease, and cause of pneumothorax. Vital signs of all patients, including heart rate, SpO2, and blood pressure, will be routinely recorded. 2. Once discharged then in an out-patient setting - symptom assessment VAS for breathlessness and pain, chest x-ray findings, and FOT readings recorded at their follow-up appointments as clinically indicated by the treating team. 3. In-patient setting - symptom assessment including VAS score for breathlessness and pain, chest x-ray, and FOT readings recorded regularly until discharge. 4. The final assessment is when the lungs are expanded or up to 3 months of follow-up, whichever is earlier. FOT is a simple non-invasive lung function assessment. It involves 2-3 minutes of breathing through a small machine at rest. All patients will have their FOT parameters assessed. Resistance (R) at different frequencies, Reactance (Xrs) and the pattern of FOT recordings will be recorded. Chest x-ray is a routine way monitoring pneumothorax. The size of pneumothorax are calculated using Collins method and ImageJ software. The patient will be enrolled if the treating physician deems it safe to proceed. All consenting patients will be monitored during FOT measurement. Vital signs, including respiratory rate, pulse rate, blood pressure, and oxygen saturation (SpO2), will be closely monitored during and after FOT