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临床试验/NCT06376942
NCT06376942尚未招募2 期

A Randomized, Double-blind, Placebo-controlled Trial to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2024年4月24日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Nebulized glycopyrronium 50 mcg (2 ml) administered via a jet nebulizer over 10 minutes

干预措施: Glycopyrronium (Drug)

Ipratropium

Active Comparator

Nebulized ipratropium bromide 500 mcg (2 ml) administered via a jet nebulizer over 10 minutes

干预措施: Ipratropium (Drug)

Saline

Placebo Comparator

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

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ritesh Agarwal

Professor of Pulmonary Medicine

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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