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

NCT ID: NCT01742195

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Satisfaction

Keywords

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Endobronchial ultrasound Bronchoscopy Patient satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nasal EBUS insertion

Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose.

Group Type OTHER

Nasal EBUS insertion

Intervention Type PROCEDURE

Oral EBUS insertion

Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth.

Group Type OTHER

Oral EBUS insertion

Intervention Type PROCEDURE

Interventions

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Oral EBUS insertion

Intervention Type PROCEDURE

Nasal EBUS insertion

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Antoine Delage

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stéphane Beaudoin, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Simon Martel, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Antoine Delage, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 26705010 (View on PubMed)

Other Identifiers

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IUCPQ-20871

Identifier Type: -

Identifier Source: org_study_id