Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope
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|ClinicalTrials.gov Identifier: NCT01742195|
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : September 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Satisfaction||Procedure: Oral EBUS insertion Procedure: Nasal EBUS insertion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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|
- Patient comfort and satisfaction [ Time Frame: Two hours after endobronchial ultrasound ]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) ]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 ]Measured in minutes.
- Total doses of sedation [ Time Frame: Immediately after the procedure (within 10 minutes) ]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 ]
- Proportion of adequate cytology specimens in each group [ Time Frame: Days after the procedure (results usually available within 10 days) ]
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): 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|