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OpenTrials
Completed

NCT Number: NCT01742195

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral EBUS insertion

Procedure

Nasal EBUS insertion

Procedure

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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