Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope
The aim of this study is to determine if the insertion of the linear endobronchial ultrasound bronchoscope is more comfortable for patients when done through the nose compared to its insertion through the mouth. Our hypothesis is that nasal insertion is more comfortable.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound|
- Patient comfort and satisfaction [ Time Frame: Two hours after endobronchial ultrasound ] [ Designated as safety issue: No ]Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.
- Physician's assessment of patient comfort [ Time Frame: Immediately after the procedure (within 10 minutes) ] [ Designated as safety issue: No ]Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties.
- Duration of endobronchial ultrasound procedure [ Time Frame: During the procedure ] [ Designated as safety issue: No ]Measured in minutes.
- Total doses of sedation [ Time Frame: Immediately after the procedure (within 10 minutes) ] [ Designated as safety issue: No ]Total doses of each sedative used will be recorded.
- Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia [ Time Frame: During the procedure and up to two hours after ] [ Designated as safety issue: Yes ]
- Proportion of adequate cytology specimens in each group [ Time Frame: Days after the procedure (results usually available within 10 days) ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Nasal EBUS insertion
Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose.
|Procedure: Nasal EBUS insertion|
Oral EBUS insertion
Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth.
|Procedure: Oral EBUS insertion|
Linear endobronchial ultrasound (EBUS) now plays a crucial role in the diagnosis, staging, and treatment planning of lung cancer. Most centers perform linear EBUS via the oral route given the larger diameter of the bronchoscope used. However, the feasibility and the diagnostic accuracy of linear EBUS performed through the nose have not been reported. Furthermore, the two routes of insertion have never been compared in terms of patient satisfaction and comfort.
In order to compare the two routes of insertion, consecutive patients referred for a linear endobronchial ultrasound will be recruited. Participants will be randomized to either oral or nasal insertion. All participants will be sedated and will receive local anesthetics in a similar manner. After the procedure, patients will fill a questionnaire regarding their comfort and satisfaction with the procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742195
|Institut Universitaire de Cardiologie et de Pneumologie de Québec|
|Québec, Quebec, Canada, G1V 4G5|
|Principal Investigator:||Stéphane Beaudoin, MD||Laval University|
|Principal Investigator:||Simon Martel, MD||Laval University|
|Principal Investigator:||Antoine Delage, MD||Laval University|