Equally of Delivery Systems of Local Anesthesia in BronchoscopyTNANCT02237651
Topical Anesthesia / Bronchoscopy
An observational study of Equally of Delivery Systems of Local Anesthesia in Bronchoscopy, run by Hannover Medical School at 1 site in Germany.
Trial summary
The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany in terms of patient… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Equally of Delivery Systems of Local Anesthesia in Bronchoscopy
- What is being tested?
- topical anesthesia multi-use device and topical anesthesia Intranasal Mucosal Atomization
- Type of treatment
- Medical device
- How many people
- 252 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Apr 2015
- Phase
- Observational
- 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after lung transplantation
Who may be able to join
- patients after lung transplantation (single, double or combined)
- Informed consent
- outpatient bronchoscopy
Who cannot join
- Oxygen requirement at rest
- Need for peri-interventional sedation
- limited German language skills or other reasons which might impair patient communication or computer handling
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dep. Respiratory Medicine, Hannover Medical School
Hanover, 30625
About this study
Official title: Topical Nasopharyngeal Anesthesia in Outpatient Bronchoscopy
The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.
Read the detailed description
Patients included in the first half of the study (topical anesthesia with the Laryngeal atomizer) and with need for another bronchoscopy in the second half of the study (topical anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the questionnaire after the second bronchoscopy to allow in-patient comparison.
Description of the primary efficacy analysis and population:
The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.
- Being tested
- topical anesthesia multi-use device, topical anesthesia Intranasal Mucosal Atomization
- Keywords
- anesthesia, bronchosocopy, lung transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical anesthesia multi-use deviceDevice
Also called anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany
topical anesthesia Intranasal Mucosal AtomizationDevice
Also called single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia
| Study group | Role | What they receive |
|---|---|---|
| topical anesthesia multi-use device | anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany Receives: Device: topical anesthesia multi-use device | |
| topical anesthesia Intranasal Mucosal Atomization | single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia Receives: Device: topical anesthesia Intranasal Mucosal Atomization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equally
The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.
Measured: 30 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
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 Equally of Delivery Systems of Local Anesthesia in BronchoscopyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Fuehner, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237651
- Sponsor's protocol ID
- MHH 09/03/2014
- Acronym
- TNA
- Status last verified
- Apr 2015
- First submitted
- 9 Sep 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fuehner T, Fuge J, Jungen M, Buck A, Suhling H, Welte T, Gottlieb J, Greer M. Topical Nasal Anesthesia in Flexible Bronchoscopy--A Cross-Over Comparison between Two Devices. PLoS One. 2016 Mar 15;11(3):e0150905. doi: 10.1371/journal.pone.0150905. eCollection 2016.
PubMed 26978775
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Nasopharyngeal Anesthesia in Outpatient Bronchoscopy
- ClinicalTrials.gov ID
- NCT02237651
- Acronym / sponsor ID
- TNA / MHH 09/03/2014
- Keywords
- anesthesia, bronchosocopy, lung transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Sep 2014 (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 primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.
Detailed description
Patients included in the first half of the study (topical anesthesia with the Laryngeal atomizer) and with need for another bronchoscopy in the second half of the study (topical anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the questionnaire after the second bronchoscopy to allow in-patient comparison.
Description of the primary efficacy analysis and population:
The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical anesthesia multi-use device | – | Device: topical anesthesia multi-use deviceanesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany |
| topical anesthesia Intranasal Mucosal Atomization | – | Device: topical anesthesia Intranasal Mucosal Atomizationsingle-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after lung transplantation
Key inclusion criteria (3 listed)
- patients after lung transplantation (single, double or combined)
- Informed consent
- outpatient bronchoscopy
Key exclusion criteria (3 listed)
- Oxygen requirement at rest
- Need for peri-interventional sedation
- limited German language skills or other reasons which might impair patient communication or computer handling
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 |
|---|---|---|
| topical anesthesia multi-use deviceAlso: anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany | Device | topical anesthesia multi-use device |
| topical anesthesia Intranasal Mucosal AtomizationAlso: single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia | Device | topical anesthesia Intranasal Mucosal Atomization |
Primary outcome
Equally
Time frame: 30 min.
The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.
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 20 Aug 2015.
- Derived from this study: PubMed 26978775Fuehner T, Fuge J, Jungen M, Buck A, Suhling H, Welte T, Gottlieb J, Greer M. Topical Nasal Anesthesia in Flexible Bronchoscopy--A Cross-Over Comparison between Two Devices. PLoS One. 2016 Mar 15;11(3):e0150905. doi: 10.1371/journal.pone.0150905. eCollection 2016.
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.
Thomas Fuehner, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Equally of Delivery Systems of Local Anesthesia in Bronchoscopy, run by Hannover Medical School at 1 site in Germany.
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 3 inclusion and 3 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 20 Aug 2015. 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 Germany. 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?
Equally (time frame: 30 min.). 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 NCT02237651, 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 20 Aug 2015.