A Randomized, Double-blind, Placebo-controlled Trial to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Cough count
研究概览
简要总结
No study has examined the role of inhaled glycopyrrolate on mucus secretion. We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion, thereby decreasing cough, and thus improving patient comfort during bronchoscopy. In this study, we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy.
详细描述
Bronchoscopy is a minimally invasive endoscopic technique for direct visualization of airways, with diagnostic and therapeutic intent. In 1897, Killian laid the foundation of bronchoscopy by extracting an animal bone from the right main bronchus of a farmer using rigid esophagoscope. In 1966, Shigeto Ikeda developed a prototype of flexible bronchoscope. Since its inception, flexible bronchoscope has undergone advancements in design and technology. The technological advancements in the recent decades have improved diagnostic yield and safety, with low morbidity and mortality. Unfortunately, the occurrence of cough during flexible bronchoscopy makes the procedure difficult and increases procedure time with patient discomfort.
Owing to the lack of clinical benefits and possible hemodynamic changes, the British Thoracic Society and Joint Indian Chest Society recommend not to use anticholinergic premedication via the parenteral route for preventing cough before bronchoscopy.
bronchoscopy. A few studies have evaluated inhaled anticholinergic premedication. Inoue et al. (in 1994) studied the effects of inhaled ipratropium bromide on bronchoconstriction in 29 subjects underwent for diagnostic bronchoscopy. They concluded that ipratropium protects against the deleterious effects resulting from topical lidocaine anesthesia during bronchoscopy. Wang et al. evaluated the efficacy of ipratropium bromide in 250 patients in a placebo-controlled trial. They reported that nebulized ipratropium bromide could reduce airway secretions and patient discomfort.
To our knowledge, no study has examined the role of inhaled glycopyrrolate on mucus secretion. We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion, thereby decreasing cough, and thus improving patient comfort during bronchoscopy.
In this study, we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with indication for flexible bronchoscopy will be enrolled in the study if they meet all the following criteria:
- •age ≥18 years
- •hemodynamically stable
- •willing to provide a written informed consent
排除标准
- •Patients with any of the following will be excluded:
- •intubated or tracheostomized patients
- •patients with airway stent in situ
- •patients with a history of glaucoma
- •baseline oxygen saturation <90%
- •patients with hemodynamic instability (SBP <90 mm Hg)
- •patients undergoing sedation for bronchoscopy
- •failure to provide informed consent
研究组 & 干预措施
Glycopyrronium
Nebulized glycopyrronium 50 mcg (2 ml) administered via a jet nebulizer over 10 minutes
干预措施: Glycopyrronium (Drug)
Ipratropium
Nebulized ipratropium bromide 500 mcg (2 ml) administered via a jet nebulizer over 10 minutes
干预措施: Ipratropium (Drug)
Saline
Nebulized saline 0.9% (2 ml) administered via a jet nebulizer over 10 minutes
干预措施: Saline (Other)
结局指标
主要结局
Cough count
时间窗: Intra-procedure
Objectively measured using condenser microphone and voice recording application though a smartphone
次要结局
- Operator-rated secretions on a visual analogue scale (VAS)(Immedidate post-procedure)
- Operator-estimated airway secretion(Intra-procedure)
- Operator-rated cough intensity on a visual analogue scale (VAS)(Immedidate post-procedure)
- Patient-rated comfort on a visual analogue scale (VAS)(Immedidate post-procedure)
- Adverse reactions(1-hour post-procedure)
研究者
Ritesh Agarwal
Professor of Pulmonary Medicine
Post Graduate Institute of Medical Education and Research, Chandigarh
