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

Sponsor
University of Florida (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02372760
Collaborator
(none)
0
1
2
10
0

Study Details

Study Description

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
  • Device: BA by spray catheter (Olympus PW-205V)
  • Other: BA classic anesthesia
  • Drug: Anesthesia
N/A

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 Design

Study Type:
Interventional
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 :
Feb 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

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 Names:
  • Spray catheter
  • Drug: Anesthesia
    Both groups will receive lidocaine as the anesthesia for bronchoscopy
    Other Names:
  • 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 Names:
  • Lidocaine
  • Outcome Measures

    Primary Outcome Measures

    1. Number of coughing episodes during the bronchoscopy [Day 1]

      Coughing data will be collected from both groups during the bronchoscopy

    2. Severity of cough during the bronchoscopy [Day 1]

      Severity of cough data will be collected from both groups during the bronchoscopy

    3. Endotracheal sedations required to conduct the bronchoscopy [Day 1]

      Endotracheal sedations required to conduct the bronchoscopy between the two groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UF Health Jacksonville Florida United States 32209

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Adil Shujaat, MD, University at Buffalo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT02372760
    Other Study ID Numbers:
    • UFJ 2014-47
    First Posted:
    Feb 26, 2015
    Last Update Posted:
    Dec 3, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by University of Florida
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2015