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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742195
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : September 11, 2013
Information provided by (Responsible Party):
Antoine Delage, 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.

Condition or disease Intervention/treatment Phase
Satisfaction Procedure: Oral EBUS insertion Procedure: Nasal EBUS insertion Not Applicable

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  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound
Study Start Date : November 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Patient comfort and satisfaction [ Time Frame: Two hours after endobronchial ultrasound ]
    Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.

Secondary Outcome Measures :
  1. Physician's assessment of patient comfort [ Time Frame: Immediately after the procedure (within 10 minutes) ]
    Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties.

  2. Duration of endobronchial ultrasound procedure [ Time Frame: During the procedure ]
    Measured in minutes.

  3. Total doses of sedation [ Time Frame: Immediately after the procedure (within 10 minutes) ]
    Total doses of each sedative used will be recorded.

  4. Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia [ Time Frame: During the procedure and up to two hours after ]
  5. Proportion of adequate cytology specimens in each group [ Time Frame: Days after the procedure (results usually available within 10 days) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742195

Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Principal Investigator: Stéphane Beaudoin, MD Laval University
Principal Investigator: Simon Martel, MD Laval University
Principal Investigator: Antoine Delage, MD Laval University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Antoine Delage, MD, Laval University Identifier: NCT01742195     History of Changes
Other Study ID Numbers: IUCPQ-20871
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by Antoine Delage, Laval University:
Endobronchial ultrasound
Patient satisfaction