For A More Comfortable Bronchoscopy: Is Spray Catheter The Answer?

Not Applicable

Withdrawn

• Conditions: Airway Complication of Anaesthesia
• Interventions: Other: BA classic anesthesia; Device: BA by spray catheter (Olympus PW-205V); Drug: Anesthesia

• Registration Number: NCT02372760
• Lead Sponsor: University of Florida

Brief Summary

Bronchoscopy is a commonly performed procedure for inpatients to visualize the airways when indicated. It is routinely done for both diagnostic (to lavage and biopsy the respiratory tract) and therapeutic purposes (to relief an obstruction or remove foreign bodies). Given the possible side effects of cough of varying severity this procedure can be uncomfortable to patients, some would even shy away from having a bronchoscopy even when it's medically indicated.

Recently a spray catheter was designed to deliver more uniform anesthesia to the airways as compared to the conventional way of injecting the anesthesia into the bronchoscopy working channel. The investigators aim to conduct this study with the hope of improving patient care, providing comfortable procedures, helping more patients opt in for bronchoscopy when indicated.

Detailed Description

Bronchoscopy is a commonly performed procedure for inpatients. It is routinely done for both diagnostic and therapeutic purposes. The physician in this procedure inserts the bronchoscopy tube that has a camera at its tip to visualize the airways and detect possible pathologies. When needed, he/she can take samples (biopsies), perform brochoalveolar lavage, remove foreign bodies, or relieve airway obstructions.

The usual method of Bronchoscopic Anesthesia (BA) is conscious sedation combined with local anesthesia as it's more comfortable for the patients, with less chances of lidocaine toxicity. Local anesthesia is classically done using lidocaine injected through the bronchoscope's working channel. As the operator starts from the upper airway, they anesthetize each part as they go down to examine the lungs. The lidocaine will be delivered to the airway as it drips out of the working channel into the airway part closest to it. Side effects of this method is cough with varying frequencies/severity that may sometimes hinder the procedure.

Recently, a spray catheter was designed and used, but mainly for EBUS (Endobronchial Ultrasound) and not for bronchoscopy.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients (18 years of age and above)
• Not mechanically ventilated
• Needing a bronchoscopy as determined by a referring or consulting physician/medical service

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Exclusion Criteria

• Individuals below 18 years of age
• Pregnant women
• Terminally-ill patients
• Patients who are unable to consent in person
• Patients with contraindications for bronchoscopy (according to British Thoracic Society 2013 Guidelines this includes patients with acute myocardial infarction and patients in acute respiratory distress)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BA classic anesthesia	BA classic anesthesia	This group will be having the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
BA classic anesthesia	Anesthesia	This group will be having the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
BA by spray catheter (Olympus PW-205V)	Anesthesia	This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V).
BA by spray catheter (Olympus PW-205V)	BA by spray catheter (Olympus PW-205V)	This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V).

Primary Outcome Measures

Name	Time	Method
Endotracheal sedations required to conduct the bronchoscopy	Day 1	Endotracheal sedations required to conduct the bronchoscopy between the two groups.
Severity of cough during the bronchoscopy	Day 1	Severity of cough data will be collected from both groups during the bronchoscopy
Number of coughing episodes during the bronchoscopy	Day 1	Coughing data will be collected from both groups during the bronchoscopy

Trial Locations

Locations (1)

UF Health; 🇺🇸 Jacksonville, Florida, United States