Topical Anesthesia / 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.

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Key information

Conditions

Equally of Delivery Systems of Local Anesthesia in Bronchoscopy

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. Respiratory Medicine, Hannover Medical School

Hanover, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

topical anesthesia multi-use device

Device

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

topical anesthesia Intranasal Mucosal Atomization

Device

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

Primary outcomes

Equally

Time frame: 30 min.

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

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

Topical Nasopharyngeal Anesthesia in Outpatient Bronchoscopy

Acronym: TNA

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Sep 11, 2014
Registry last updated: Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.