SatisfactionNCT01742195
Comparison of Patient Comfort With the Nasal and Oral Insertion of the Endobronchial Ultrasound Bronchoscope
A study testing Oral EBUS insertion and Nasal EBUS insertion in people with Satisfaction, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Satisfaction
- What is being tested?
- Oral EBUS insertion and Nasal EBUS insertion
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older than 18 years of age
- patients referred for a first linear endobronchial ultrasound
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound
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.
Read the 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.
- Conditions
- Satisfaction
- Being tested
- Oral EBUS insertion, Nasal EBUS insertion
- Keywords
- Endobronchial ultrasound, Bronchoscopy, Patient satisfaction
- Medical subject headings
- Personal Satisfaction, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral EBUS insertionProcedure or surgery
Nasal EBUS insertionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Nasal EBUS insertion | Other | Patients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose. Receives: 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. Receives: Procedure: Oral EBUS insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort and satisfaction
Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.
Measured: Two hours after endobronchial ultrasound
Secondary outcomes (5)
Physician's assessment of patient comfort
Measured by a questionnaire using a 10-point Likert scale regarding patient comfort and procedural difficulties.
Measured: Immediately after the procedure (within 10 minutes)
Duration of endobronchial ultrasound procedure
Measured in minutes.
Measured: During the procedure
Total doses of sedation
Total doses of each sedative used will be recorded.
Measured: Immediately after the procedure (within 10 minutes)
Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia
Measured: During the procedure and up to two hours after
Proportion of adequate cytology specimens in each group
Measured: Days after the procedure (results usually available within 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SatisfactionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Delage, Laval University
- Investigators
- Stéphane Beaudoin, MD, Principal investigator, Laval UniversitySimon Martel, MD, Principal investigator, Laval UniversityAntoine Delage, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742195
- Sponsor's protocol ID
- IUCPQ-20871
- Status last verified
- Sep 2013
- First submitted
- 28 Nov 2012
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26705010
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound
- ClinicalTrials.gov ID
- NCT01742195
- Acronym / sponsor ID
- IUCPQ-20871
- Conditions
- Satisfaction
- Keywords
- Endobronchial ultrasound, Bronchoscopy, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal EBUS insertion | Other | Procedure: Nasal EBUS insertionPatients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the nose. |
| Oral EBUS insertion | Other | Procedure: Oral EBUS insertionPatients in this arm will undergo a linear endobronchial ultrasound with the bronchoscope inserted through the mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients older than 18 years of age
- patients referred for a first linear endobronchial ultrasound
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral EBUS insertion | Procedure or surgery | Oral EBUS insertion |
| Nasal EBUS insertion | Procedure or surgery | Nasal EBUS insertion |
Primary outcome
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.
5 secondary outcomes
Physician's assessment of patient comfort
Time frame: Immediately after the procedure (within 10 minutes)
Duration of endobronchial ultrasound procedure
Time frame: During the procedure
Total doses of sedation
Time frame: Immediately after the procedure (within 10 minutes)
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
Proportion of adequate cytology specimens in each group
Time frame: Days after the procedure (results usually available within 10 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
- Derived from this study: PubMed 26705010Beaudoin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Beaudoin, MD principal investigator
Laval University
Simon Martel, MD principal investigator
Laval University
Antoine Delage, MD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral EBUS insertion and Nasal EBUS insertion in people with Satisfaction, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort and satisfaction (time frame: Two hours after endobronchial ultrasound). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.