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

Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742195
• Other study ID #: IUCPQ-20871
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: September 10, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Satisfaction

Intervention

Procedure:
• Oral EBUS insertion

• Nasal EBUS insertion

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient comfort and satisfaction	Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.	Two hours after endobronchial ultrasound	No
Secondary	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)	No
Secondary	Duration of endobronchial ultrasound procedure	Measured in minutes.	During the procedure	No
Secondary	Total doses of sedation	Total doses of each sedative used will be recorded.	Immediately after the procedure (within 10 minutes)	No
Secondary	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	Yes
Secondary	Proportion of adequate cytology specimens in each group		Days after the procedure (results usually available within 10 days)	No