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

L

Laval University

Status

Completed

Conditions

Satisfaction

Treatments

Procedure: Nasal EBUS insertion
Procedure: Oral EBUS insertion

Study type

Interventional

Funder types

Other

Identifiers

NCT01742195
IUCPQ-20871

Details and patient eligibility

About

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.

Full 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.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 2 patient groups

Nasal EBUS insertion
Other group
Description:
Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose.
Treatment:
Procedure: Nasal EBUS insertion
Oral EBUS insertion
Other group
Description:
Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth.
Treatment:
Procedure: Oral EBUS insertion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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