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

Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01742195

Enrollment

220

Registered

2012-12-05

Start date

2012-11-30

Completion date

2013-06-30

Last updated

2013-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Satisfaction

Keywords

Endobronchial ultrasound, Bronchoscopy, Patient satisfaction

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.

Interventions

PROCEDUREOral EBUS insertion

PROCEDURENasal EBUS insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026