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

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

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.

Study Overview

• Status: Completed
• Conditions: Satisfaction
• Intervention / Treatment: Procedure: Nasal EBUS insertion; Procedure: Oral EBUS insertion

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Principal Investigator: Stéphane Beaudoin, MD, Laval University; Principal Investigator: Simon Martel, MD, Laval University; Principal Investigator: Antoine Delage, MD, Laval University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): September 11, 2013
• Last Update Submitted That Met QC Criteria: September 10, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Patient satisfaction; Bronchoscopy; Endobronchial ultrasound
• Other Study ID Numbers: IUCPQ-20871