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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antoine Delage, Laval University
ClinicalTrials.gov Identifier:
NCT01742195
First received: November 28, 2012
Last updated: September 10, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


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 ]

Enrollment: 220
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
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: September 10, 2013
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 November 20, 2014