Topical Anesthesia / Bronchoscopy (TNA)

August 19, 2015 updated by: Hannover Medical School

Topical Nasopharyngeal Anesthesia in Outpatient 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Dep. Respiratory Medicine, Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients after lung transplantation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Equally
Time Frame: 30 min.
The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.
30 min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (ESTIMATE)

September 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHH 09/03/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Equally of Delivery Systems of Local Anesthesia in Bronchoscopy

Clinical Trials on topical anesthesia multi-use device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe