Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound

Conditions
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Satisfaction

Intervention / Treatment
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* Procedure: Oral EBUS insertion
* Procedure: Nasal EBUS insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients older than 18 years of age patients referred for a first linear endobronchial ultrasound Exclusion Criteria: Patients who previously underwent an EBUS Patients intubated with an endotracheal tube Patients under the age of 18 Patients unable to provide informed consent Patients currently taking anticoagulants (therapeutic doses of intravenous or subcutaneous heparin, low-molecular weight heparins, direct thrombin inhibitors or other agents) Patients taking anti-platelet therapy other than aspirin (clopidogrel, ticagrelor, prasugrel). A period of 7 days off medication is required before participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nasal EBUS insertion<br>Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose. | Procedure: Nasal EBUS insertion<br> <br> |
| Other: Oral EBUS insertion<br>Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth. | Procedure: Oral EBUS insertion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial ultrasound, Bronchoscopy, Patient satisfaction