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CompletedNCT02237651TNAUpdated Aug 20, 2015

Topical Anesthesia / Bronchoscopy

An observational study in Equally of Delivery Systems of Local Anesthesia in Bronchoscopy, sponsored by Hannover Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2015-08-20.

Sponsored by Hannover Medical School · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
252
Ages
18 Years to 88 Years
Sex
All
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Study 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 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.

02

Conditions studied

  • Equally of Delivery Systems of Local Anesthesia in Bronchoscopy

Keywords

  • anesthesia
  • bronchosocopy
  • lung transplantation
03

In context

Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 88 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients after lung transplantation

Inclusion criteria

  • patients after lung transplantation (single, double or combined)
  • Informed consent
  • outpatient bronchoscopy

Exclusion criteria

Exclusion Criteria:

  • Oxygen requirement at rest
  • Need for peri-interventional sedation
  • limited German language skills or other reasons which might impair patient communication or computer handling
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
252 participants (actual)
Patient registry
No

Groups and cohorts

  • topical anesthesia multi-use device

    anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany

    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

    Device: topical anesthesia Intranasal Mucosal Atomization

Interventions

  • Devicetopical anesthesia multi-use device

    Also known as: anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany

  • Devicetopical anesthesia Intranasal Mucosal Atomization

    Also known as: single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia

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What researchers measure

Primary outcomes

  1. Equally

    The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.

    Time frame: 30 min.

07

Study locations

1 site
  • Dep. Respiratory Medicine, Hannover Medical School
    Hannover, 30625, Germany
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02237651
Lead sponsor
Hannover Medical School
Responsible party
Sponsor
First posted
Sep 11, 2014
Start date
Sep 2014
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Aug 20, 2015

Study contacts

Thomas Fuehner, MD
principal investigator · Hannover Medical School

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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