Clinical trial NCT01742195: Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope
Official title: Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction
Keywords: Endobronchial ultrasound
Bronchoscopy
Patient satisfaction
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient comfort and satisfaction
timeFrame: Two hours after endobronchial ultrasound
Secondary outcomes:
measure: Physician's assessment of patient comfort
timeFrame: Immediately after the procedure (within 10 minutes)
measure: Duration of endobronchial ultrasound procedure
timeFrame: During the procedure
measure: Total doses of sedation
timeFrame: Immediately after the procedure (within 10 minutes)
measure: Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia
timeFrame: During the procedure and up to two hours after
measure: Proportion of adequate cytology specimens in each group
timeFrame: Days after the procedure (results usually available within 10 days)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
state: Quebec
Study officials:
affiliation: Laval University
name: Stéphane Beaudoin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Simon Martel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Antoine Delage, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.