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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372760
Recruitment Status : Withdrawn (The PI has relocated and the study has been closed.)
First Posted : February 26, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Airway Complication of Anaesthesia Device: BA by spray catheter (Olympus PW-205V) Other: BA classic anesthesia Drug: Anesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: For A More Comfortable Bronchoscopy: Is Spray Catheter The Answer?
Study Start Date : February 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BA by spray catheter (Olympus PW-205V)
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)
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V)
Other Name: Spray catheter

Drug: Anesthesia
Both groups will receive lidocaine as the anesthesia for bronchoscopy
Other Name: Lidocaine

Active Comparator: BA classic anesthesia
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
Other: BA classic anesthesia
This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.

Drug: Anesthesia
Both groups will receive lidocaine as the anesthesia for bronchoscopy
Other Name: Lidocaine




Primary Outcome Measures :
  1. Number of coughing episodes during the bronchoscopy [ Time Frame: Day 1 ]
    Coughing data will be collected from both groups during the bronchoscopy

  2. Severity of cough during the bronchoscopy [ Time Frame: Day 1 ]
    Severity of cough data will be collected from both groups during the bronchoscopy

  3. Endotracheal sedations required to conduct the bronchoscopy [ Time Frame: Day 1 ]
    Endotracheal sedations required to conduct the bronchoscopy between the two groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372760


Locations
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United States, Florida
UF Health
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Adil Shujaat, MD University at Buffalo
Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02372760    
Other Study ID Numbers: UFJ 2014-47
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by University of Florida:
Bronchoscopic anesthesia lidocaine
Spray Catheter
brochoalveolar lavage
Additional relevant MeSH terms:
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Lidocaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action