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Topical Anesthesia / Bronchoscopy (TNA)

H

Hannover Medical School (MHH)

Status

Completed

Conditions

Equally of Delivery Systems of Local Anesthesia in Bronchoscopy

Treatments

Device: topical anesthesia Intranasal Mucosal Atomization
Device: topical anesthesia multi-use device

Study type

Observational

Funder types

Other

Identifiers

NCT02237651
MHH 09/03/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

252 patients

Sex

All

Ages

18 to 88 years old

Volunteers

No Healthy Volunteers

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

Trial design

252 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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