跳至主要内容
临床试验/NCT05616780
NCT05616780已完成不适用

Does Severity of Airflow Obstruction Correlate to Static Lung Volumes Obtained by Nitrogen Washout and Body Plethysmography?

Virginia Hawkins2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Measurement of lung volumes by two routine techniques in patients referred for pulmonary function testing.

研究概览

简要总结

Obstructive lung disease is defined by limitations in expiratory airflow, caused by excess mucus, loss of muscle tone, and structural changes. Over time airflow reduction can lead to gas trapping in the lungs (hyperinflation). Hyperinflation is linked to diminished exercise tolerance, shortness of breath, and a poor quality of life. Early treatment options include inhalers and pulmonary rehabilitation; however, surgical intervention and oxygen therapy may be required in the later stages. More prompt, accurate diagnosis will help to improve patient outcomes and optimise their treatment pathways.

Two methodologies used to determine lung volumes and hyperinflation, are nitrogen washout and body plethysmography. The accuracy of each in defining lung volumes in patients with obstructive lung disease is debated in literature. Plethysmography requires the patient to sit in an enclosed box and perform a panting manoeuvre and uses measured changes in volume and pressure to derive lung volumes. Plethysmography has been suggested to overestimate lung volumes in patients with obstructive lung disease. On the other hand, nitrogen washout relies on 'washing out' all the nitrogen from the lungs to calculate lung volumes. Gas trapping and poor airflow circulation that occurs in patients with airflow obstruction may lead to underestimated lung volumes.

This study will aim to investigate if there is a significant difference between lung volumes obtained by both nitrogen washout and body plethysmography in patients with obstructive lung disease. Subjects with mild, moderate, severe, and very severe obstruction, including those with no obstruction for comparison will be included, with approximately 10 from each group. They will be asked if they consent to undergo an extra test during their routine hospital appointment, which will add ~15 minutes to their visit.

详细描述

Obstructive lung disease is defined by limitations in expiratory airflow, caused by excess mucus, loss of muscle tone, and structural changes. Over time airflow reduction can lead to gas trapping in the lungs (hyperinflation). Hyperinflation is linked to diminished exercise tolerance, shortness of breath, and a poor quality of life. Early treatment options include inhalers and pulmonary rehabilitation; however, surgical intervention and oxygen therapy may be required in the later stages. More prompt, accurate diagnosis will help to improve patient outcomes and optimise their treatment pathways.

Two methodologies used to determine lung volumes and hyperinflation, are nitrogen washout and body plethysmography. The accuracy of each in defining lung volumes in patients with obstructive lung disease is debated in literature. Plethysmography requires the patient to sit in an enclosed box and perform a panting manoeuvre and uses measured changes in volume and pressure to derive lung volumes. Plethysmography has been suggested to overestimate lung volumes in patients with obstructive lung disease. On the other hand, nitrogen washout relies on 'washing out' all the nitrogen from the lungs to calculate lung volumes. Gas trapping and poor airflow circulation that occurs in patients with airflow obstruction may lead to underestimated lung volumes.

This study will aim to investigate if there is a significant difference between lung volumes obtained by both nitrogen washout and body plethysmography in patients with obstructive lung disease. Subjects with mild, moderate, severe, and very severe obstruction, including those with no obstruction for comparison will be included, with approximately 10 from each group. They will be asked if they consent to undergo an extra test during their routine hospital appointment, which will add ~15 minutes to their visit.

Expiratory airflow limitation is the hallmark of obstructive pulmonary disease; Parenchymal remodelling, mucous impaction, oedema, and a decrease of smooth muscle tone all contribute to the structural and anatomical changes that occur (O'Donnell, 2006). Individuals with bronchiectasis and chronic obstructive pulmonary disease often have inflammation in their airways (COPD). Impaired mucociliary clearance and increased mucus production are caused by inflammation that occurs inside the airway epithelium. Because of increased connective tissue deposition, the bronchial walls thicken, and the lumen of the airways decrease over time (Hogg, 2004). Airflow obstruction is defined as a reduction in expiratory airflow when compared to the total volume of air exhaled and is investigated by a test called spirometry. The two measurements required to identify obstructive lung disease are FEV1 (forced expiratory volume in the first second of expiration following a maximal inspiration) and FVC (forced vital capacity - the maximal amount of air that can be exhaled forcibly following maximal inhalation). For airflow obstruction to be diagnosed the FEV1/FVC ratio of must be <70%. The FEV1 percent predicted is then used to determine the severity of obstruction following this. Spirometry is commonly used to identify the presence of COPD (chronic obstruction pulmonary disease) or the severity/absence of obstruction in diseases such as asthma (Eschenbacher, 2016). TLC (total lung capacity) describes the amount of air in the lungs at maximal inspiration, the expected amount is determined by height, age, weight, ethnicity and gender. Chest wall deformities, tumours, level of physical activity and the presence of respiratory disease can all alter an individual's TLC.

Often, as a result of chronic obstructive lung disease, hyperinflation occurs which is the abnormal increase in FRC. This is caused by the imbalance between the reduction in airflow from the lungs compared to the total volume of the lungs. Changes in elastic properties of the lungs and impaired inspiratory muscle function also contribute to the extent of hyperinflation over time (Gibson, 1996). Hyperinflation is associated with reduced exercise capacity, dyspnoea and reduced quality of life. Individuals with COPD were found to spend 1/3 of the day standing/walking compared to healthy individuals of the same age who spent around ½ of the day doing so; such physical deconditioning significantly accelerates disease progression (Cooper, 2009). Treatment and intervention that targets hyperinflation can improve not only respiratory symptoms but also metabolic parameters and chronic inflammation. Pulmonary rehabilitation, bronchodilators and oxygen therapy are often utilised, however, surgical intervention such as lung volume reduction surgery (LVRS) is believed to provide the most benefit (Criner, 2017). The accuracy of lung volume measurements is vital to determine if interventional treatment (e.g., bronchodilators, LVRS, supplemental oxygen) have been successful or if a patient needs surgical intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A minimum of 10 patients from each group will be included; normal lung function/ no airflow obstruction (FEV1/FVC >70%), mild airflow obstruction (FEV1/FVC <70% and FEV1 >80% predicted), moderate airflow obstruction (FEV1/FVC <70% and FEV1 50-80% predicted), severe airflow obstruction (FEV1/FVC <70% and FEV1 30-50% predicted) and very severe (FEV1/FVC <70% and FEV1 >30% predicted).
  • Al patients will be over the age of 18 with no upper age limit. No children will be included in this study.
  • Patients must have withheld their inhalers.

排除标准

  • [15:10] Jessica Armstrong
  • Contraindications to performing the test include (if occurred within last 8 weeks):
  • Heart attack
  • Haemoptysis
  • Pneumothorax
  • Surgery to the abdomen/thorax
  • Eye surgery
  • An individuals spirometry cannot be included if:
  • There is a cough during the first second of the manoeuvre
  • A leak at the mouthpiece
  • Early termination of manoeuvre
  • Sub optimal effort
  • They are unable to comprehend the instructions
  • Obstruction of the mouthpiece (tongue/teeth)
  • Lung volume measurements cannot be included if:
  • There is a leak around the mouthpiece
  • The patient has a ruptured eardrum
  • They are unable to comprehend the instructions
  • Obstruction of the mouthpiece (tongue/teeth)
  • The patient is on supplementary oxygen and cannot come off it (this must be discontinued for a suitable period prior to nitrogen washout)
  • Patients who are CO2 retainers may not be able to undergo nitrogen washout
  • The patients test results must meet the acceptability criteria of the ARTP pulmonary function testing statement (updated 2020). For spirometry this states that there must be 3 technically acceptable attempts within 150ml, however, if the the individual has an FVC <1.00L this can be 100ml. Nitrogen washout requires two technically acceptable attempts within 10% (as per trust policy), whereas, for body plethysmography three technically acceptable attempts should be obtained within 5%.

结局指标

主要结局

Measurement of lung volumes by two routine techniques in patients referred for pulmonary function testing.

时间窗: 6 months

Patients referred for pulmonary function test as part of their routine patient treatment pathway will have lung volumes measured by nitrogen washout and body plethysmography, which are both routine techniques. Participants will have a range of obstructive or normal lung function. When the test is finished, patients will be told that their test results will be sent to their consultant, who will then explain them at a follow up appointment/ phone call (this is routine procedure).

次要结局

未报告次要终点

研究者

发起方
Virginia Hawkins
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Virginia Hawkins

Chief Investigator

Manchester Metropolitan University

研究点 (2)

Loading locations...

相似试验