Subjects Undergoing Flexible Bronchoscopy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGGlycopyrronium
Nebulized glycopyrronium 50 mcg
DRUGIpratropium
Nebulized iptratropium 500 mcg
OTHERSaline
0.9% saline 2 ml
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough count | Intra-procedure | Objectively measured using condenser microphone and voice recording application though a smartphone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operator-estimated airway secretion | Intra-procedure | Recorded as: almost none, needing saline to wash out, and excessive, making it difficult to visualize the airways and requires 5 ml aliquots of saline |
| Operator-rated secretions on a visual analogue scale (VAS) | Immedidate post-procedure | 100 mm VAS anchored as no secretion at one and maximal secretions at the other |
| Operator-rated cough intensity on a visual analogue scale (VAS) | Immedidate post-procedure | 100 mm VAS anchored as no cough at one and maximal cough at the other |
| Patient-rated comfort on a visual analogue scale (VAS) | Immedidate post-procedure | 100 mm VAS anchored as maximal comfort at one and maximal discomfort at the other |
| Adverse reactions | 1-hour post-procedure | Arrhythmia, glaucoma, nausea, headache |
Countries
India
Contacts
Primary ContactRitesh Agarwal
Backup ContactInderpaul Sehgal
Outcome results
None listed