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

December 1, 2015 updated by: University of Florida

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
Drug: Anesthesia
Both groups will receive lidocaine as the anesthesia for bronchoscopy
Other Names:
  • Lidocaine
Other: BA classic anesthesia
This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFJ 2014-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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