An interventional study of BA by spray catheter (Olympus PW-205V) and BA classic anesthesia in Airway Complication of Anaesthesia, sponsored by University of Florida. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-03.
Sponsored by University of Florida · Not applicable and Interventional
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.
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.
University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V).
Device: BA by spray catheter (Olympus PW-205V) · Drug: Anesthesia
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
Other: BA classic anesthesia · Drug: Anesthesia
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V)
Also known as: Spray catheter
This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
Both groups will receive lidocaine as the anesthesia for bronchoscopy
Also known as: Lidocaine
Number of coughing episodes during the bronchoscopy
Coughing data will be collected from both groups during the bronchoscopy
Time frame: Day 1
Severity of cough during the bronchoscopy
Severity of cough data will be collected from both groups during the bronchoscopy
Time frame: Day 1
Endotracheal sedations required to conduct the bronchoscopy
Endotracheal sedations required to conduct the bronchoscopy between the two groups.
Time frame: Day 1
This study is withdrawn, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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