Smoking Cessation Before Intervention in Patients With Pulmonary Nodules Requiring Further Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Smoking Cessation
研究概览
简要总结
Nicotine is the most common preventable cause of death and is responsible for over seven million deaths worldwide. If current trends continue, tobacco will kill more than eight million people worldwide every year by 2030. Smoking tobacco products is the most important risk factor for the development of lung cancer. Passive smoking is also a major cause of lung cancer. Since July 2024, smokers and former smokers have been able to receive a low-radiation CT scan under certain conditions to detect lung cancer at an early stage. It is therefore to be expected that the number of diagnoses of pulmonary lesions or nodules will increase in the near future. The risk of developing and dying from tobacco-related diseases is reduced once nicotine cessation begins. Screening all patients for tobacco use, e-cigarette use, and providing behavioral counseling and pharmacotherapy to quit smoking are among the most valuable preventive services we can offer in healthcare.
Nicotine dependence can be estimated using the so-called Fagerström test. An additional evaluation of nicotine behavior can be carried out by testing cotinine in urine, a method that is used, for example, in the listing for lung transplantation. Cotinine is a degradation product of nicotine that can be detected in the urine of smokers and passive smokers. Cotinine levels in urine depend on the frequency and quantity of nicotine consumption. The half-life of cotinine is 16 to 22 hours, which means that half of the cotinine is excreted from the body after this time. Another marker that can be used as a measure of tobacco consumption is carboxyhaemoglobin (COHb). This is hemoglobin with carbon monoxide at the binding site for oxygen. The reference range for carboxyhaemoglobin is 0.4 - 1.6 %. In smokers, values of 3-10 % are still considered normal.
In our department, the smoking status of patients is assessed upon first contact. Support options for smoking cessation are offered and, upon request, initiated. Previous studies have shown that smoking is a risk factor for complications after thoracic surgical procedures and that patients who underwent thoracic surgery quit smoking almost twice as often compared to patients who did not undergo surgery. However, to the best of our knowledge, there is currently no study regarding smoking cessation before intervention in patients with nodules needing clarification (bronchoscopy or CT-guided puncture).
Therefore, the aim of the study is to support and monitor smoking cessation before intervention in patients with nodules needing further diagnosis (bronchoscopy or CT-guided puncture).
详细描述
Patients who present to our outpatient clinic for the evaluation of a concerning round lesion (V1) are asked during the medical history taking whether they currently smoke. If the question is answered affirmatively, patients are urgently advised to quit smoking immediately. Support options for smoking cessation are presented, and if desired, a connection to a smoking cessation counseling program of the Federal Institute for Public Health ('rauchfrei ticket') is established. Furthermore, nicotine dependence is assessed using the Fagerström test, while COHb is determined through blood gas analysis and cotinine is measured in urine. During the planned result discussion (V2) after the inpatient stay for histological confirmation (either via bronchoscopy or CT-guided puncture), patients are asked if they have quit smoking and COHb and cotinine are measured again. After 3 months (V3), these values will be measured conclusively. In addition, the following data will be collected and documented from the patients: age, gender, height, weight, current medication, other illnesses, and current body plethysmography. Participation in the study does not change the course of the patients' stay in our clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is an active smoker by the time of the initial presentation in our pneumological outpatient clinic for the clarification of a suspicious nodule
排除标准
- •Current or past medically relevant illness or treatment that could affect the evaluability of the study.
- •Expected lack of willingness to actively participate in study-related measures.
研究组 & 干预措施
Smoking cessated
Patients who have stopped smoking since they were informed that they have a pulmonary lesion that needs clarification or after the diagnosis of cancer was communicated.
Smoking not cessated
Patients who have not stopped smoking since they were informed that they have a pulmonary lesion that needs clarification or after the diagnosis of cancer was communicated.
结局指标
主要结局
Smoking Cessation
时间窗: From enrollment to the end of the observation period 3 months later
Patients who visit our outpatient clinic for the purpose of investigating a pulmonary lesion that requires clarification, are asked during the medical history if they are active smokers. If the answer is yes, patients are strongly advised to stop smoking immediately. Support options for smoking cessation are presented and, if desired, a connection to a smoking cessation counseling program offered by the Federal Institute for Public Health ("rauchfrei ticket") is established. In addition, nicotine dependence is assessed using the Fagerström test, COHb is determined by blood gas analysis, and cotinine is determined in urine. The same parameters will bei measured after 2-4 weeks and 3 months. As primary outcome measure, the number of patients who are likely to be smoke-free at the end of the observation period will be assessed.
次要结局
- Analysis of demographic data(Within 3 months)
- Spirometry (Lungfunction)(Within 3 Months)
- Bodyplethysmography (Lungfunction)(Within 3 months)
- Diffusing capacity (lungfunction)(Within 3 months)
研究者
Jens Spießhöfer
PD Dr.Dr.med
RWTH Aachen University