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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal EBUS insertion | Other | Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose. |
|
| Oral EBUS insertion | Other | Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral EBUS insertion | Procedure |
| ||
| Nasal EBUS insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Patient comfort and satisfaction | Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction. | Two hours after endobronchial ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's assessment of patient comfort | Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties. | Immediately after the procedure (within 10 minutes) |
| Duration of endobronchial ultrasound procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Beaudoin, MD | Laval University | Principal Investigator |
| Simon Martel, MD | Laval University | Principal Investigator |
| Antoine Delage, MD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | Quebec | G1V 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26705010 | Derived | Beaudoin S, Martel S, Pelletier S, Lampron N, Simon M, Laberge F, Delage A. Randomized Trial Comparing Patient Comfort Between the Oral and Nasal Insertion Routes for Linear Endobronchial Ultrasound. J Bronchology Interv Pulmonol. 2016 Jan;23(1):39-45. doi: 10.1097/LBR.0000000000000249. |
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
Measured in minutes. |
| During the procedure |
| Total doses of sedation | Total doses of each sedative used will be recorded. | Immediately after the procedure (within 10 minutes) |
| Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia | During the procedure and up to two hours after |
| Proportion of adequate cytology specimens in each group | Days after the procedure (results usually available within 10 days) |