NCT01742195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

7 months

First QC Date

November 28, 2012

Last Update Submit

September 10, 2013

Conditions

Satisfaction

Keywords

Endobronchial ultrasoundBronchoscopyPatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Patient comfort and satisfaction

    Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.

    Two hours after endobronchial ultrasound

Secondary Outcomes (5)

  • Physician's assessment of patient comfort

    Immediately after the procedure (within 10 minutes)

  • Duration of endobronchial ultrasound procedure

    During the procedure

  • Total doses of sedation

    Immediately after the procedure (within 10 minutes)

  • 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)

Study Arms (2)

Nasal EBUS insertion

OTHER

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

Procedure: Nasal EBUS insertion

Oral EBUS insertion

OTHER

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

Procedure: Oral EBUS insertion

Interventions

Oral EBUS insertionPROCEDURE
Oral EBUS insertion
Nasal EBUS insertionPROCEDURE
Nasal EBUS insertion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients older than 18 years of age
  • patients referred for a first linear endobronchial ultrasound

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26705010DERIVED

MeSH Terms

Conditions

Personal SatisfactionPatient Satisfaction

Condition Hierarchy (Ancestors)

BehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Stéphane Beaudoin, MD

    Laval University

    PRINCIPAL INVESTIGATOR

  • Simon Martel, MD

    Laval University

    PRINCIPAL INVESTIGATOR

  • Antoine Delage, MD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 28, 2012

First Posted

December 5, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 11, 2013

Record last verified: 2013-09

Locations

CA(1)