Topical Anesthesia / Bronchoscopy

Completed

• Conditions: Equally of Delivery Systems of Local Anesthesia in Bronchoscopy
• Interventions: Device: topical anesthesia Intranasal Mucosal Atomization; Device: topical anesthesia multi-use device

• Registration Number: NCT02237651
• Lead Sponsor: Hannover Medical School

Brief 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.

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Equally	30 min.	The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.

Trial Locations

Locations (1)

Dep. Respiratory Medicine, Hannover Medical School; 🇩🇪 Hannover, Germany