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

Not Applicable

Completed

• Conditions: Satisfaction
• Interventions: Procedure: Nasal EBUS insertion; Procedure: Oral EBUS insertion

• Registration Number: NCT01742195
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-10
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal EBUS insertion	Nasal EBUS insertion	Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose.
Oral EBUS insertion	Oral EBUS insertion	Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth.

Primary Outcome Measures

Name	Time	Method
Patient comfort and satisfaction	Two hours after endobronchial ultrasound	Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.

Secondary Outcome Measures

Name	Time	Method
Physician's assessment of patient comfort	Immediately after the procedure (within 10 minutes)	Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties.
Duration of endobronchial ultrasound procedure	During the procedure	Measured in minutes.
Total doses of sedation	Immediately after the procedure (within 10 minutes)	Total doses of each sedative used will be recorded.
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)

Trial Locations

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec; 🇨🇦 Québec, Quebec, Canada