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

This study is currently recruiting participants.

Verified December 2012 by Laval University

Sponsor:

Information provided by (Responsible Party):

Antoine Delage, Laval University

ClinicalTrials.gov Identifier:

NCT01742195

First received: November 28, 2012

Last updated: December 21, 2012

Last verified: December 2012

History of Changes

Purpose

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	Intervention
Satisfaction	Procedure: Oral EBUS insertion Procedure: Nasal EBUS insertion

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound

Further study details as provided by Laval University:

Primary Outcome Measures:

Patient comfort and satisfaction [ Time Frame: Two hours after endobronchial ultrasound ] [ Designated as safety issue: No ]
Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.

Secondary Outcome Measures:

Physician's assessment of patient comfort [ Time Frame: Immediately after the procedure (within 10 minutes) ] [ Designated as safety issue: No ]
Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties.
Duration of endobronchial ultrasound procedure [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
Measured in minutes.
Total doses of sedation [ Time Frame: Immediately after the procedure (within 10 minutes) ] [ Designated as safety issue: No ]
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 [ Time Frame: During the procedure and up to two hours after ] [ Designated as safety issue: Yes ]
Proportion of adequate cytology specimens in each group [ Time Frame: Days after the procedure (results usually available within 10 days) ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	November 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742195

Contacts

Contact: Antoine Delage, MD		antoine.delage@criucpq.ulaval.ca
Contact: Simon Martel, MD		simon.martel@fmed.ulaval.ca

Locations

Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Québec	Recruiting
Québec, Quebec, Canada, G1V 4G5
Contact: Antoine Delage, MD antoine.delage@criucpq.ulaval.ca
Contact: Simon Martel, MD simon.martel@fmed.ulaval.ca
Sub-Investigator: Simon Martel, MD
Sub-Investigator: Stéphane Beaudoin, MD
Principal Investigator: Antoine Delage, MD

Sponsors and Collaborators

Laval University

Investigators

Principal Investigator:	Stéphane Beaudoin, MD	Laval University
Principal Investigator:	Simon Martel, MD	Laval University
Principal Investigator:	Antoine Delage, MD	Laval University

More Information

No publications provided

Responsible Party:	Antoine Delage, MD, Laval University
ClinicalTrials.gov Identifier:	NCT01742195 History of Changes
Other Study ID Numbers:	IUCPQ-20871
Study First Received:	November 28, 2012
Last Updated:	December 21, 2012
Health Authority:	Canada: Canadian Institutes of Health Research Canada: Health Canada

Keywords provided by Laval University:

Endobronchial ultrasound
Bronchoscopy
Patient satisfaction

ClinicalTrials.gov processed this record on May 19, 2013

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