Comparison of Two Different Types of "Spray as You go" Technique for Awake Fiberoptic Intubation

NCT ID: NCT01995292

Last Updated: 2014-11-06

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to determine whether modified "spray as you go" technique using the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for the patient.

Detailed Description

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Conditions

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Awake Fiberoptic Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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bronchoscope

Patients will receive local anaesthetics via the working channel of the bronchoscope.

Group Type EXPERIMENTAL

bronchoscope

Intervention Type DEVICE

Enk Fiberoptic Atomizer

Patients will receive local anaesthetics for the awake fiberoptic intubation via the Enk Fiberoptic Atomizer.

Group Type EXPERIMENTAL

Enk Fiberoptic Atomizer

Intervention Type DEVICE

Interventions

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bronchoscope

Intervention Type DEVICE

Enk Fiberoptic Atomizer

Intervention Type DEVICE

Other Intervention Names

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Standard procedure: Instillation of local anesthetics via the working channel of the bronchoscope Nebulization of local anesthetics with the Enk Fiberoptic Atomizer during awake fiberoptic intubation

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* no concurrent participation in another clinical trial
* German language in speaking and writing
* Capability of giving consent
* written informed consent
* an elective surgery under general anesthesia, in which an awake fiberoptic intubation is indicated

Exclusion Criteria

* Age \< 18 years
* pregnant women
* patients unwilling or unable to give informed consent
* ASA classification \> 3
* Known allergy to local anesthetics
* Participation in another clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Nina Pirlich, Dr. med.

Dr. med. Nina Pirlich

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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Atomizer1.0

Identifier Type: -

Identifier Source: org_study_id

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