Topical Anesthesia / Bronchoscopy

NCT ID: NCT02237651

Last Updated: 2015-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Equally of Delivery Systems of Local Anesthesia in Bronchoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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topical anesthesia multi-use device

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

topical anesthesia multi-use device

Intervention Type DEVICE

topical anesthesia Intranasal Mucosal Atomization

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

topical anesthesia Intranasal Mucosal Atomization

Intervention Type DEVICE

Interventions

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topical anesthesia multi-use device

Intervention Type DEVICE

topical anesthesia Intranasal Mucosal Atomization

Intervention Type DEVICE

Other Intervention Names

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anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Fuehner, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Dep. Respiratory Medicine, Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26978775 (View on PubMed)

Other Identifiers

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MHH 09/03/2014

Identifier Type: -

Identifier Source: org_study_id

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