TCTR20240709001招募中3 期
Effectiveness of Nebulized Bronchodilator - Enhanced Sputum Induction Versus Conventional Sputum Induction in Thai Patients with Clinically Suspected Smear-Negative Pulmonary Tuberculosis; A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Thai patients aged 18 years or older.
- •2. Exhibiting clinical symptoms or radiological findings consistent with pulmonary tuberculosis, and suspected by the attending physician to have pulmonary tuberculosis or pulmonary tuberculosis in conjunction with extrapulmonary tuberculosis.
- •3. Initial sputum examination (spot sputum) shows no evidence of tuberculosis through acid-fast bacilli staining and Xpert MTB/RIF Ultra testing, or patients unable to produce effective sputum samples due to insufficient cough strength.
- •4. Not currently undergoing treatment for tuberculosis or latent tuberculosis.
- •5. Voluntarily consent to participate in the research and sign the informed consent form.
排除标准
- •1. Pregnant women.
- •2. Patients with bronchospasm or a history of severe bronchospasm induced by sputum induction, or a history of pulmonary function tests showing a decrease in FEV1 by more than 20% post-sputum induction.
- •3. Patients with severe respiratory issues, including:
- •3.1. Severe or uncontrolled asthma, meeting at least one of the following criteria:
- •3.1.1. Exhibiting more than three of the following symptoms:
- •(a) Daytime breathlessness more than twice a week.
- •(b) Nighttime breathlessness more than once a week.
- •(c) Use of emergency inhalation medication more than twice a week.
- •(d) Asthma symptoms affecting daily activities at least once a week (Activity limitation).
- •3.1.2. History of pulmonary function tests with FEV1 less than 60% of the predicted value by age, or less than 1 liter, or peak expiratory flow rate variability greater than 30%.
- •3.1.3. Asthma exacerbation within 4 weeks prior to study participation.
- •3.2. Severe emphysema, meeting at least one of the following criteria:
- •3.2.1. Classified as GOLD classification 3 or higher.
- •3.2.2. History of pulmonary function tests with FEV1 less than 50% of the predicted value by age.
- •3.2.3. Emphysema exacerbation within 4 weeks prior to study participation.
- •4. Patients with severe or uncontrolled comorbidities that the physician deems could pose a risk during sputum induction, whether by standard methods or using bronchodilator-assisted induction. These conditions include severe arrhythmias, heart failure or acute myocardial ischemia, severe hypoxemia, high levels of hepatic or renal insufficiency, unconsciousness or unresponsiveness, or uncontrolled epilepsy.
- •5. Patients currently using bronchodilator inhalers who cannot discontinue their use for at least 6-12 hours.
- •6. Patients with an allergy to the bronchodilators Ipratropium bromide or Fenoterol hydrobromide.
- •7. Patients or their relatives who do not consent to participation in the study.
- •8. Patients who do not cooperate or are unable to follow instructions for sputum induction (excluding patients with disabilities, such as limb impairment or blindness, who can still cooperate and follow instructions).
- •9. Patients requiring or unable to discontinue the following medications: aclidinium, beta-2 agonists (e.g., terbutaline, dopamine, dobutamine, norepinephrine), cimetropium, eluxadoline, glycopyrrolate, kratom, levosulpiride, loxapine, oxatomide, pramlintide, revefenacin, umeclidinium.
- •10. Patients receiving medications that are components of tuberculosis treatment regimens and have direct activity against Mycobacterium tuberculosis for other therapeutic indications for more than 2 weeks, such as Rifampicin for endocarditis or Levofloxacin for bacterial infections.
研究者
相似试验
招募中
不适用
Clinical efficacy of bronchodilator delivery by vibrating mesh nebulizer in mechanical ventilated patientsPatients: Spontaneously breathing patients on mechanical ventilation with airway resistance of higher than 6 cmH2O/L/sec measured by PAV+.JPRN-UMIN000048137Tokyo Bay Urayasu Ichikawa Medical Center50
招募中
3 期
Comparison of bronchodilator nebulization via high flow oxygen therapy and jet nebulization in acute asthma exacerbation children; A randomized controlled studyAn acute severe asthma exacerbation in children aged 2-15 yearssevere asthma exacerbation, HFNC, high flow nasal cannulas, nebulizationTCTR20230707006Faculty of Medicine, Thammasat University48
终止
不适用
Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation in COPDChronic Obstructive Pulmonary Disease (COPD)Type 2 Respiratory FailureNCT03481543National University Health System, Singapore11
招募中
4 期
Evaluation of the Use of Guaco Syrup for Dilation and Reduction of Inflammation in the Respiratory Tract Through Pulmonary Function Tests in Asthmatic VolunteersAsthmaC08.127.108RBR-4n26tfniversidade federal do paraná
已完成
不适用
Efficacy of long-acting bronchodilators on dynamic lung hyperinflation in chronic obstructive pulmonary disease.Chronic obstructive pulmonary disease (COPD)JPRN-UMIN000027446Shinshu University School of Health Sciences30