A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy

Phase 2

Not yet recruiting

• Conditions: Subjects Undergoing Flexible Bronchoscopy
• Interventions: Drug: Ipratropium; Other: Saline; Drug: Glycopyrronium

• Registration Number: NCT06376942
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-22
• Last Update Posted: 2024-04-22
• Study Start: 2024-04-24
• Primary Completion: 2025-04-25
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1050

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ipratropium	Ipratropium	Nebulized ipratropium bromide 500 mcg (2 ml) administered via a jet nebulizer over 10 minutes
Saline	Saline	Nebulized saline 0.9% (2 ml) administered via a jet nebulizer over 10 minutes
Glycopyrronium	Glycopyrronium	Nebulized glycopyrronium 50 mcg (2 ml) administered via a jet nebulizer over 10 minutes

Primary Outcome Measures

Name	Time	Method
Cough count	Intra-procedure	Objectively measured using condenser microphone and voice recording application though a smartphone

Secondary Outcome Measures

Name	Time	Method
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-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 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

Trial Locations

Locations (1)

Bronchoscopy suite, PGIMER; 🇮🇳 Chandigarh, India